Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application
Regeneron Pharmaceuticals (NASDAQ: REGN) has received a Complete Response Letter (CRL) from the FDA regarding their supplemental Biologics License Application for EYLEA HD® (aflibercept) Injection 8 mg. The application sought to extend dosing intervals up to 24 weeks across all approved indications.
The FDA did not identify any safety or efficacy concerns with EYLEA HD's currently approved indications and dosing regimens but rejected the proposal for additional extended dosing intervals beyond the current maximum of 16 weeks. EYLEA HD maintains its existing approval for dosing intervals of 8-16 weeks for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and 8-12 weeks for diabetic retinopathy (DR), following 3 initial monthly doses.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha ricevuto una Lettera di Risposta Completa (CRL) dalla FDA riguardo alla loro domanda supplementare di Licenza Biologica per EYLEA HD® (iniezione di aflibercept) 8 mg. La richiesta mirava a estendere gli intervalli di somministrazione fino a 24 settimane per tutte le indicazioni approvate.
La FDA non ha riscontrato problemi di sicurezza o efficacia con le indicazioni e i regimi posologici attualmente approvati per EYLEA HD, ma ha respinto la proposta di ulteriori estensioni degli intervalli di somministrazione oltre l'attuale massimo di 16 settimane. EYLEA HD mantiene quindi l'approvazione esistente per intervalli di somministrazione da 8 a 16 settimane per la degenerazione maculare senile umida (wAMD) e l'edema maculare diabetico (DME), e da 8 a 12 settimane per la retinopatia diabetica (DR), dopo 3 dosi mensili iniziali.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha recibido una Carta de Respuesta Completa (CRL) de la FDA respecto a su solicitud suplementaria de Licencia Biológica para EYLEA HD® (inyección de aflibercept) 8 mg. La solicitud buscaba extender los intervalos de dosificación hasta 24 semanas para todas las indicaciones aprobadas.
La FDA no identificó problemas de seguridad o eficacia con las indicaciones y regímenes de dosificación actualmente aprobados para EYLEA HD, pero rechazó la propuesta de intervalos de dosificación extendidos más allá del máximo actual de 16 semanas. EYLEA HD mantiene su aprobación vigente para intervalos de dosificación de 8 a 16 semanas para la degeneración macular húmeda relacionada con la edad (wAMD) y el edema macular diabético (DME), y de 8 a 12 semanas para la retinopatía diabética (DR), tras 3 dosis mensuales iniciales.
Regeneron Pharmaceuticals (NASDAQ: REGN)는 EYLEA HD® (아플리버셉트 주사 8mg)에 대한 보충 생물학적 허가 신청과 관련하여 FDA로부터 완전 반응서(CRL)를 받았습니다. 이번 신청은 승인된 모든 적응증에 대해 투여 간격을 최대 24주까지 연장하는 것을 목표로 했습니다.
FDA는 EYLEA HD의 현재 승인된 적응증 및 투여 요법에 대해 안전성이나 효능 문제를 발견하지 않았으나, 현재 최대 16주인 투여 간격을 초과하는 추가 연장 제안은 거부했습니다. EYLEA HD는 따라서 3회의 초기 월별 투여 후 습성 연령 관련 황반변성(wAMD)과 당뇨황반부종(DME)에 대해 8~16주, 당뇨망막병증(DR)에 대해 8~12주의 기존 투여 간격 승인을 유지합니다.
Regeneron Pharmaceuticals (NASDAQ : REGN) a reçu une lettre de réponse complète (CRL) de la FDA concernant leur demande complémentaire d'autorisation de mise sur le marché biologique pour EYLEA HD® (injection d’aflibercept) 8 mg. La demande visait à étendre les intervalles de dosage jusqu’à 24 semaines pour toutes les indications approuvées.
La FDA n’a relevé aucune préoccupation de sécurité ou d’efficacité concernant les indications et schémas posologiques actuellement approuvés pour EYLEA HD, mais a rejeté la proposition d’intervalles de dosage prolongés au-delà du maximum actuel de 16 semaines. EYLEA HD conserve son approbation existante pour des intervalles de dosage de 8 à 16 semaines pour la dégénérescence maculaire liée à l’âge humide (wAMD) et l’œdème maculaire diabétique (DME), ainsi que de 8 à 12 semaines pour la rétinopathie diabétique (DR), après 3 doses initiales mensuelles.
Regeneron Pharmaceuticals (NASDAQ: REGN) hat von der FDA ein vollständiges Antwortschreiben (Complete Response Letter, CRL) bezüglich ihres ergänzenden Antrags auf Biologika-Zulassung für EYLEA HD® (Aflibercept-Injektion 8 mg) erhalten. Der Antrag zielte darauf ab, die Dosierungsintervalle für alle zugelassenen Indikationen auf bis zu 24 Wochen zu verlängern.
Die FDA stellte keine Sicherheits- oder Wirksamkeitsbedenken bei den derzeit zugelassenen Indikationen und Dosierungsplänen von EYLEA HD fest, lehnte jedoch den Vorschlag für zusätzliche verlängerte Dosierungsintervalle über das derzeitige Maximum von 16 Wochen hinaus ab. EYLEA HD behält seine bestehende Zulassung für Dosierungsintervalle von 8 bis 16 Wochen bei feuchter altersbedingter Makuladegeneration (wAMD) und diabetischem Makulaödem (DME) sowie 8 bis 12 Wochen bei diabetischer Retinopathie (DR) nach 3 anfänglichen monatlichen Dosen bei.
- No safety or efficacy concerns identified with current approved indications
- Maintains existing approved dosing regimens across all indications
- FDA rejected proposal for extended dosing intervals beyond 16 weeks
- Potential limitation on product differentiation and market competitiveness
TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD® (aflibercept) Injection 8 mg across all approved indications.
The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label). Regeneron is evaluating the FDA’s decision and will determine a path forward in due course.
EYLEA HD is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), following 3 initial monthly doses.
About EYLEA HD
Over a decade ago, Regeneron introduced EYLEA, a vascular endothelial growth factor inhibitor, and transformed the treatment paradigm for certain serious chorioretinal vascular diseases. With a well-established efficacy and consistent safety profile from 16 pivotal trials, EYLEA is approved to treat vision-threatening conditions that impact patients from their earliest days, such as retinopathy of prematurity (ROP), to their later years, including diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO) and wet age-related macular degeneration (wAMD).
Pushing the boundaries of science further to meet patient needs, EYLEA HD was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a robust body of research and is currently approved in the U.S. to treat patients with wAMD, DME and DR.
EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. Regeneron maintains exclusive rights to EYLEA and EYLEA HD in the U.S. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD.
About Ophthalmology Development at Regeneron
At Regeneron, we relentlessly pursue groundbreaking innovations in eye care science to help maintain the eye health of the millions of Americans impacted by vision-threatening conditions. Our expertise in angiogenesis and decades of research serve as our foundation, fueling our ongoing ambition to further innovate new solutions for patients. Our robust and diverse research and development program in ophthalmology includes efforts to potentially address additional serious eye diseases, including geographic atrophy (ongoing Phase 3 SIENNA clinical trial), glaucoma and certain inherited retinal diseases.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
INDICATIONS
EYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
EYLEA® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg).
IMPORTANT SAFETY INFORMATION
- EYLEA HD and EYLEA are administered by injection into the eye. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept.
- Injections into the eye with EYLEA HD or EYLEA can result in an infection in the eye, retinal detachment (separation of retina from back of the eye) and, more rarely, serious inflammation of blood vessels in the retina that may include blockage. Call your doctor right away if you or your baby (if being treated with EYLEA for Retinopathy of Prematurity) experience eye pain or redness, light sensitivity, or a change in vision after an injection.
- In some patients, injections with EYLEA HD or EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.
- In infants with Retinopathy of Prematurity (ROP), treatment with EYLEA will need extended periods of ROP monitoring.
- There is a potential but rare risk of serious and sometimes fatal side effects, related to blood clots, leading to heart attack or stroke in patients receiving EYLEA HD or EYLEA.
- The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, increased pressure in the eye, eye discomfort, pain, or irritation, blurred vision, vitreous (gel-like substance) floaters, vitreous detachment, injury to the outer layer of the eye, and bleeding in the back of the eye.
- The most common side effects reported in patients receiving EYLEA were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye.
- The most common side effects reported in pre-term infants with ROP receiving EYLEA were separation of the retina from the back of the eye, increased redness in the eye, and increased pressure in the eye. Side effects that occurred in adults are considered applicable to pre-term infants with ROP, though not all were seen in clinical studies.
- You may experience temporary visual changes after an EYLEA HD or EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers sufficiently.
- For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information for EYLEA HD and EYLEA.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates and the impact of the Complete Response Letter from the U.S. Food and Drug Administration (“FDA”) regarding the supplemental Biologics License Application for EYLEA HD discussed in this press release on any of the foregoing; whether Regeneron will ultimately be able to obtain FDA approval for additional extended dosing intervals for EYLEA HD and, if so, the timing of any such approval; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as Regeneron’s Product Candidates for the treatment of geographic atrophy, glaucoma, or other serious eye diseases referenced in this press release; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection 2 mg), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).
Contacts:
| Media Relations Julie Block Tel: +1 914-826-7083 julie.block@regeneron.com | Investor Relations Mark Hudson Tel: +1 914-847-3482 mark.hudson@regeneron.com |
FAQ
What did the FDA's Complete Response Letter say about EYLEA HD's extended dosing application?
What are the current approved dosing intervals for EYLEA HD (REGN)?
How will the FDA's rejection of extended dosing affect REGN's EYLEA HD market position?
What conditions is EYLEA HD currently approved to treat?
