AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Severe Alopecia Areata
Rhea-AI Summary
AbbVie (NYSE: ABBV) announced a positive CHMP opinion recommending approval of upadacitinib (RINVOQ) 15 mg and 30 mg once daily for adults and adolescents with severe alopecia areata in the EU. The opinion is based on Phase 3 UP-AA data showing SALT ≤ 20 and complete scalp regrowth (SALT = 0) at week 24, with a safety profile generally consistent with approved indications. A final European Commission decision is expected in the coming months.
Positive
- Positive CHMP opinion recommending EU approval of upadacitinib for severe alopecia areata
- Phase 3 UP-AA program met primary endpoint SALT ≤ 20 at week 24 for both doses
- Key secondary endpoint of complete scalp hair regrowth (SALT = 0) achieved at week 24
- Safety profile in Period A generally consistent with existing approved indications
- Once-daily 15 mg and 30 mg dosing evaluated in adults and adolescents broadens potential patient reach
Negative
- Final European Commission approval for alopecia areata indication is still pending
- Upadacitinib use in alopecia areata is not currently approved in the European Union
News Market Reaction – ABBV
In the Jun 29 session, ABBV gained 0.38%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 24 | Entrepreneur program launch | Positive | +0.1% | BOTOX Cosmetic announced grants and mentorship for 250 women entrepreneurs. |
| Jun 23 | Health Canada approval | Positive | +2.1% | Allergan Aesthetics gained Canadian approval for Boey neurotoxin for frown lines. |
| Jun 23 | EU HCV approval | Positive | +2.1% | European Commission approved MAVIRET for acute hepatitis C infection treatment. |
| Jun 23 | Pediatric psoriasis approval | Positive | +2.1% | SKYRIZI received EU approval for pediatric moderate to severe plaque psoriasis. |
| Jun 22 | Large acquisition deal | Positive | +6.6% | AbbVie agreed to acquire Apogee Therapeutics, expanding late‑stage immunology assets. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent AbbVie headlines on approvals and acquisitions have generally coincided with positive share-price reactions.
Key Terms
chmp regulatory
jak inhibitor medical
severity of alopecia tool (salt) medical
randomized, placebo-controlled, double-blind technical
phase 3 medical
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- Positive CHMP opinion is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the primary endpoint of Severity of Alopecia Tool (SALT) score ≤ 20 and key secondary endpoints, including improvements in eyebrows and eyelashes, at week 241,2
- Upadacitinib is the first JAK inhibitor to meet the stringent ranked secondary endpoint of complete scalp hair regrowth (SALT = 0) at week 241,2
"Alopecia areata is an unpredictable autoimmune disease with underrecognized patient burden," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "The CHMP's positive opinion for upadacitinib is a step closer to bringing a new treatment option to patients living with severe alopecia areata."
The CHMP positive opinion is supported by data from the ongoing Phase 3 UP-AA clinical program (M23-716), which includes two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with severe alopecia areata. Both the 15 mg and 30 mg doses of upadacitinib in each study met the primary endpoint of SALT score ≤ 20 at week 24, with significantly more patients achieving ≥
Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in AA is not currently approved in the EU.
About Alopecia Areata
Alopecia areata (AA) is an unpredictable autoimmune disease causing a range of hair loss patterns, from sudden, round bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes.3,4 Despite its immune-mediated nature, AA is often considered a cosmetic problem, which can lead to stigma and have an impact on patients' lives.5,6
About UP-AA Clinical Trial
UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. The Phase 3 randomized, placebo-controlled, double-blind studies evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata. In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks. Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in one of two groups, based on their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2 can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. The two trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide. More information on this trial can be found at www.clinicaltrials.gov (NCT06012240).
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in alopecia areata is not approved; its safety and efficacy are under regulatory review by the
EU Indications and Important Safety Information about RINVOQ® (upadacitinib)7
Indications
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Giant cell arteritis
RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn's disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Important Safety Information
Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.
Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
- patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
- patients with malignancy risk factors (e.g. current malignancy or history of malignancy)
Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.
Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.
Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.
Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.
Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.
Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.
Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active‑controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.
Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.
Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.
Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.
Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.
Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose‑dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.
Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.
Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.
Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.
Medication Residue in Stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.
Giant Cell Arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.
Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥
The most commonly reported adverse reactions in AD trials (≥
The most commonly reported adverse reactions in the UC and CD trials (≥
Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.
The most common serious adverse reactions were serious infections.
The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.
This is not a complete summary of all safety information.
See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.eu.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.
Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
References
- AbbVie. Data on file ABVRRTI81580.
- AbbVie. Data on file ABVRRTI81456.
- Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: Part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010;62(2):177-188, quiz 189-190.
- Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3(1):17011
- Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019;180(6):1377-1389
- Bain KA, McDonald E, Moffat F, et al. Alopecia areata is characterized by dysregulation in systemic type 17 and type 2 cytokines, which may contribute to disease-associated psychological morbidity. Br J Dermatol. 2020;182(1):130-137
- RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026
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