InflaRx (IFRX) rethinks European AAV path after EMA Tavneos setback
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
InflaRx N.V. is reassessing its ANCA-associated vasculitis (AAV) strategy in Europe after the EMA’s Committee for Medicinal Products for Human Use recommended revoking Tavneos’ marketing authorization in the EU. The company plans to engage EMA on two C5a/C5aR-targeting programs, vilobelimab and the oral inhibitor izicopan.
Izicopan’s Phase 2 planning in AAV continues across multiple regions, and InflaRx views vilobelimab as Phase 3-ready in AAV after two completed Phase 2 trials in the U.S. and Europe. Partner Staidson is running a Phase 3 AAV trial in China with BDB-001, a vilobelimab cell line-derived antibody.
Vilobelimab is also approved in the EU as GOHIBIC under exceptional circumstances for SARS-CoV-2-induced ARDS and has U.S. Emergency Use Authorization for certain ventilated COVID-19 patients. Prior studies showed a 23.9% relative reduction in 28‑day all‑cause mortality versus placebo, supporting its role in severe inflammatory settings.
Positive
- None.
Negative
- None.
Key Figures
Tavneos EMA action date: June 26, 2026
GOHIBIC mortality reduction: 23.9% relative reduction
Izicopan single-dose range: 3 mg to 240 mg
+4 more
7 metrics
Tavneos EMA action date
June 26, 2026
CHMP recommendation to revoke EU marketing authorization for Tavneos
GOHIBIC mortality reduction
23.9% relative reduction
28-day all-cause mortality vs placebo in Phase 3 PANAMO
Izicopan single-dose range
3 mg to 240 mg
Well tolerated in first-in-human study single-dose escalation
Izicopan multiple-dose range
30 mg QD to 90 mg BID
Dosed for 14 days with no safety signals of concern
Neutrophil activation blockade
≥90% blockade
C5a-induced neutrophil activation over 14-day izicopan dosing
BDB-001 assessment period
12 weeks
Phase 1/2 AAV trial response rates vs standard of care
Phase 3 start for BDB-001
2025
Staidson-initiated AAV Phase 3 trial in China
Key Terms
ANCA-associated vasculitis, C5a receptor (C5aR), marketing authorization under exceptional circumstances, Emergency Use Authorization, +2 more
6 terms
ANCA-associated vasculitis medical
"InflaRx Assessing Feasibility of Broadened Strategy for ANCA-Associated Vasculitis in Europe"
A condition in which the immune system mistakenly attacks and inflames blood vessels, driven by specific antibodies called ANCAs; this can reduce blood flow and damage organs such as kidneys, lungs and nerves, similar to “friendly fire” damaging the body’s plumbing. Investors should care because its rarity, severity and complex treatment needs drive clinical trial activity, regulatory scrutiny, pricing, and potential market opportunities or risks for therapies and diagnostics.
C5a receptor (C5aR) medical
"Izicopan is an orally administered, small molecule inhibitor of the C5a receptor (C5aR)"
marketing authorization under exceptional circumstances regulatory
"GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances"
Emergency Use Authorization regulatory
"GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration"
A regulatory emergency use authorization allows a government health agency to temporarily permit the use or sale of a medical product—such as a vaccine, test, or treatment—before full formal approval when there is a public health crisis. For investors, an authorization can rapidly open revenue and market access while carrying higher regulatory and demand risk, like a fast-track pass that speeds a product to customers but may still require further review and can affect a company's valuation and future sales prospects.
acute respiratory distress syndrome (ARDS) medical
"for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS)"
Acute respiratory distress syndrome (ARDS) is a sudden, severe lung condition where fluid fills the tiny air sacs and the lungs become stiff, making it hard for oxygen to get into the blood—think of lungs like sponges that have become waterlogged and rigid. It matters to investors because ARDS drives urgent hospital care, use of ventilators and monitoring equipment, and demand for drugs and therapies, so changes in its incidence or treatment can affect healthcare costs, hospital capacity and the outlook for medical companies.
Birmingham vasculitis score (BVAS) medical
"using the Birmingham vasculitis score (BVAS)"
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private
Issuer Pursuant to Rule
13a-16 or 15d-16 of the
Securities Exchange Act
of 1934
For the month of June 2026
Commission File
Number: 001-38283
InflaRx N.V.
Winzerlaer Str. 2
07745 Jena,
Germany
(+49) 3641508180
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
INCORPORATION BY REFERENCE
On June 30, 2026, InflaRx N.V. (the “Company”) issued a press release titled “InflaRx Assessing Feasibility of Broadened Strategy for ANCA-Associated Vasculitis in Europe Following EMA
Recommendation on Tavneos.”
The Company today announced that it is assessing the feasibility of broadening its development and registrational strategy for AAV in Europe. The Company has initiated this assessment given the recommendation of the
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to revoke the marketing authorization for Tavneos in the European Union, announced on June 26, 2026.
In addition, the Company announced it intends to engage with EMA regarding both its anti-C5a antibody vilobelimab, which is approved under exceptional circumstances as GOHIBIC in Europe for SARS-CoV-2-induced acute
respiratory distress syndrome, in addition to its next-generation oral C5aR inhibitor izicopan. This will be part of the Company’s overall development goal to determine the most efficient development pathway to bring the C5a / C5aR inhibition
mechanism to patients. Together, vilobelimab and izicopan provide the Company with a complementary biologic and oral pipeline that is well positioned to address the evolving treatment landscape and significant unmet medical need in AAV.
A copy of the press release is attached as Exhibit 99.1 to this Report. Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,”
“plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this Report and may include statements
regarding our intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the headings, “Risk factors” and “Cautionary statement regarding forward-looking statements,” in
our periodic filings with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this Report and involve known and unknown risks, uncertainties and other important factors that may cause our actual results,
performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.
EXHIBIT INDEX
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Exhibit No.
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Description
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99.1
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Press Release, dated June 30, 2026
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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INFLARX N.V.
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Date: June 30, 2026
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By:
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/s/ Niels Riedemann
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Name: Niels Riedemann
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Title: Chief Executive Officer
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Exhibit 99.1
InflaRx Assessing Feasibility of Broadened Strategy for ANCA-Associated Vasculitis in Europe Following EMA Recommendation on Tavneos
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InflaRx intends to engage with EMA regarding both vilobelimab and izicopan to evaluate the regulatory path to approval in ANCA-associated vasculitis (AAV)
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The Company is assessing the most efficient development plan to bring the C5a/C5aR inhibition mechanism to patients
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Previously announced Phase 2 planning with izicopan in AAV continues uninterrupted
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Jena, Germany, June 30, 2026 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by
targeting the complement system, today announced it is assessing the feasibility of broadening its development and registrational strategy for AAV in Europe. The company has initiated this assessment given the recommendation of the European
Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to revoke the marketing authorization for Tavneos in the European Union, announced on June 26, 2026.
The Company announced it intends to engage with EMA regarding both its anti-C5a antibody vilobelimab, which is approved under exceptional circumstances as GOHIBIC in Europe for SARS-CoV-2-induced
acute respiratory distress syndrome, in addition to its next-generation oral C5aR inhibitor izicopan. This will be part of the Company´s overall development goal to determine the most efficient development pathway to bring the C5a/C5aR inhibition
mechanism to patients. The previously announced Phase 2 planning with izicopan in AAV continues as planned and uninterrupted across multiple geographies.
InflaRx considers vilobelimab to be a Phase 3-ready asset in AAV, where it has completed two Phase 2 studies in the U.S. and Europe. In addition, BDB-001, a
vilobelimab cell line-produced antibody, has completed Phase 2 development and is being evaluated by InflaRx’s collaborator, Staidson BioPharmaceuticals Co., Ltd. (Staidson), in a Phase 3 trial in AAV in
China. Together, vilobelimab and izicopan provide InflaRx with a complementary biologic and oral pipeline that is well positioned to address the evolving treatment landscape and significant unmet medical need in AAV.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: “Recent developments in the ANCA-associated vasculitis
treatment landscape reinforce both the seriousness of this disease and the importance of therapies with a strong mechanistic rationale, robust clinical evidence and a differentiated benefit-risk profile. InflaRx has deep scientific and clinical
experience with the C5a/C5aR pathway, and with our anti-C5a antibody vilobelimab and our next-generation oral C5aR inhibitor izicopan, we have built a differentiated portfolio targeting this mechanism. We are committed to identifying the most
efficient development pathway, with an overall goal for InflaRx of maximizing the value of these programs.”
Anti-C5a therapy in AAV
A growing body of clinical data supporting the utility and safety of anti-C5a therapy in AAV has emerged in recent years.
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Vilobelimab has been evaluated in two controlled Phase 2 AAV studies, the European IXCHANGE trial (NCT03895801) and the U.S. IXPLORE trial (NCT03712345). In IXCHANGE, which tested vilobelimab as
a replacement for glucocorticoids on a background of standard-of-care rituximab or cyclophosphamide, clinical response and remission rates with vilobelimab were comparable to those achieved with standard-dose glucocorticoids, while cumulative
glucocorticoid exposure and glucocorticoid-related toxicity were substantially lower in vilobelimab-treated patients. In IXPLORE, vilobelimab added to standard of care was well tolerated without signals of safety concerns. Across both IXCHANGE and
IXPLORE, vilobelimab demonstrated a favorable safety and tolerability profile, with IXCHANGE supporting its potential to induce remission while markedly reducing the glucocorticoid burden.
In addition, under a license agreement where it holds development and commercialization rights in China, our collaborator Staidson has generated promising AAV data with BDB-001, an anti-C5a
antibody produced using the vilobelimab cell line. The multicenter, randomized, open-label, parallel-controlled Phase 1/2 clinical trial by Staidson demonstrated that BDB-001 injection combined with reduced-dose glucocorticoids or without
glucocorticoids achieved comparable partial response rates and numerically higher complete response rates at 12 weeks of treatment compared with standard of care using the Birmingham vasculitis score (BVAS). After successful completion of this
Phase 1/2 study, Staidson initiated a Phase 3 trial in China in 2025, which is ongoing.
About AAV
AAV is a rare, life-threatening autoimmune disease characterized by inflammation and damage to small blood vessels, with patients often experiencing serious organ involvement, including renal
impairment. InflaRx believes the recent regulatory developments underscore the continued need for well-characterized, mechanistically targeted therapies that may help address the significant unmet medical need in this disease.
About izicopan
Izicopan is an orally administered, small molecule inhibitor of the C5a receptor (C5aR) that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in
contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan does not exhibit time-dependent inhibition of cytochrome P450 3A4 (CYP3A4), which plays an important role in the metabolism of a variety of metabolites and
drugs, including glucocorticoids. Izicopan has also demonstrated a favorable reactive metabolite profile in human liver microsomes. Reported results from a first-in-human study demonstrated that izicopan was well tolerated in treated subjects and
exhibited no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of
izicopan, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with
hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules and draining tunnels, robust HiSCR responses that continued to deepen four weeks after the treatment period,
and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7)
broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7). In addition, InflaRx is planning for development of izicopan in AAV and additional renal
indications.
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About vilobelimab
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human
blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has
been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response.
In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress
syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). The EU approval of GOHIBIC is supported by the
previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed
that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set. The data were published in The Lancet Respiratory Medicine.
A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that
comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC’s approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study by the Biomedical Advanced Research
and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.
In the U.S., GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated
within 48 hours of receiving IMV or ECMO. The emergency use of GOHIBIC is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the
COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.
GOHIBIC (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There is limited information known about the
safety and effectiveness of using GOHIBIC to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on
the GOHIBIC website http://www.gohibic.com.
Important Safety Information about GOHIBIC (vilobelimab)
There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use.
GOHIBIC has been associated with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC.
Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.
The most common adverse reactions (incidence ≥3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection,
bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious AEs or deaths that occur during GOHIBIC treatment and are
considered to be potentially attributable to GOHIBIC.
Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de.
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For the full prescribing information and additional important safety information, please visit www.GOHIBIC.com.
About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and
specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx‘s lead program is izicopan, an orally
administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The Company is developing izicopan for
the treatment of AAV and additional renal diseases. InflaRx also has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying
clinical activity and tolerability in multiple clinical studies.
InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and
InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
Contacts:
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InflaRx N.V.
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MC Services AG
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Jan Medina, CFA
Vice President, Head of Investor Relations
Email: IR@inflarx.de
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Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email: inflarx@mc-services.eu
Europe: +49 89-210 2280
U.S.: +1-339-832-0752
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FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,”
“expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include
statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the success of our future clinical trials for izicopan’s treatment of anti-neutrophil cytoplasmic AAV and other
renal diseases, including aHUS, IgAN and C3G, and our ability to establish proof-of-concept for izicopan across such indications; the success of our future clinical trials for vilobelimab’s treatment of other debilitating or life-threatening
inflammatory indications, including acute respiratory distress syndrome; potential strategic transactions or collaborations, including a potential partnership of izicopan, or vilobelimab for pyoderma gangrenosum; the success of our future clinical
trials for izicopan, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of vilobelimab,
izicopan and any other of our product candidates and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs
of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our biologics license application
submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the FDA, or any comparable foreign regulatory authority will accept or agree
with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and
develop therapies to treat complement-mediated immunological and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of
such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our
existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab); our estimates of
our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if
approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in
seeking marketing approval or commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and
projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the SEC. These statements
speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results,
performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update
these forward-looking statements, even if new information becomes available in the future, except as required by law.
FAQ
What did InflaRx (IFRX) announce in its June 2026 Form 6-K?
InflaRx announced it is assessing a broadened development and registrational strategy for ANCA-associated vasculitis (AAV) in Europe. This follows an EMA committee recommendation to revoke Tavneos’ EU marketing authorization and could reshape how its C5a/C5aR pipeline is positioned in this disease area.
How is the EMA Tavneos recommendation linked to InflaRx’s AAV plans?
The EMA committee’s recommendation to revoke Tavneos’ EU marketing authorization prompted InflaRx to reassess its AAV strategy. The company now plans to evaluate how vilobelimab and oral C5aR inhibitor izicopan might address evolving treatment needs and regulatory expectations for AAV patients in Europe.
What AAV clinical data support InflaRx’s vilobelimab program?
Vilobelimab has been studied in two Phase 2 AAV trials, IXCHANGE in Europe and IXPLORE in the U.S. IXCHANGE showed comparable remission outcomes to standard-dose glucocorticoids with substantially lower steroid exposure, while both trials together indicated a favorable safety and tolerability profile in treated patients.
What is izicopan and how has it performed in earlier studies?
Izicopan is an oral small molecule C5a receptor inhibitor with anti-inflammatory activity. In early studies, it was well tolerated across single and multiple dosing regimens and showed ≥90% blockade of C5a-induced neutrophil activation, plus biologic-like efficacy signals in hidradenitis suppurativa and chronic spontaneous urticaria.
What approvals does GOHIBIC (vilobelimab) currently hold?
In the EU, GOHIBIC (vilobelimab) has marketing authorization under exceptional circumstances for adult COVID-19 patients with ARDS on invasive mechanical ventilation. In the U.S., it has Emergency Use Authorization for hospitalized adults with COVID-19 when started within 48 hours of invasive mechanical ventilation or ECMO.
How strong were GOHIBIC’s survival results in COVID-19 ARDS?
In the Phase 3 PANAMO trial in invasively ventilated COVID-19 patients, vilobelimab treatment produced a 23.9% relative reduction in 28-day all-cause mortality versus placebo. These results supported EU marketing authorization under exceptional circumstances and the U.S. Emergency Use Authorization for GOHIBIC.