Regeneron Provides Update on Biologics License Application for Linvoseltamab
Regeneron Pharmaceuticals (NASDAQ: REGN) has received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for linvoseltamab, a treatment for relapsed/refractory multiple myeloma. The CRL was anticipated and relates to inspection findings at a third-party fill/finish manufacturer. The manufacturer believes the issues have been resolved and awaits FDA reinspection. Regeneron is committed to working with the manufacturer and FDA to bring linvoseltamab to market quickly. The European Medicines Agency (EMA) is still reviewing linvoseltamab for the same indication. This update is important as most multiple myeloma patients relapse and require additional therapies in late-line settings.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha ricevuto una Lettera di Risposta Completa (CRL) dalla FDA per la sua Domanda di Licenza per Biologici (BLA) per linvoseltamab, un trattamento per il mieloma multiplo recidivante/refrattario. La CRL era prevista e riguarda le scoperte emerse durante l'ispezione presso un produttore terzo di riempimento/finitura. Il produttore ritiene che i problemi siano stati risolti e attende una nuova ispezione da parte della FDA. Regeneron è impegnata a collaborare con il produttore e la FDA per portare rapidamente linvoseltamab sul mercato. L'Agenzia Europea dei Medicinali (EMA) sta ancora esaminando linvoseltamab per la stessa indicazione. Questo aggiornamento è importante poiché la maggior parte dei pazienti con mieloma multiplo recidiva e richiede terapie aggiuntive in fasi avanzate.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha recibido una Carta de Respuesta Completa (CRL) de la FDA para su Solicitud de Licencia Biológica (BLA) para linvoseltamab, un tratamiento para el mieloma múltiple en recaída/refractario. La CRL era anticipada y se relaciona con los hallazgos de la inspección en un fabricante externo de llenado/finalización. El fabricante cree que los problemas se han resuelto y está a la espera de una reinspección por parte de la FDA. Regeneron está comprometida a trabajar con el fabricante y la FDA para llevar rápidamente linvoseltamab al mercado. La Agencia Europea de Medicamentos (EMA) todavía está revisando linvoseltamab para la misma indicación. Esta actualización es importante ya que la mayoría de los pacientes con mieloma múltiple recaen y requieren terapias adicionales en etapas avanzadas.
레제너론 제약(NASDAQ: REGN)은 재발성/내성 다발성 골수종 치료제인 린보셀타맙에 대한 생물학적 의약품 허가 신청서(BLA)에 대해 FDA로부터 완전 응답서(CRL)를 받았습니다. 이 CRL은 예상된 것이며 제3자 충전/완료 제조업체의 검사 결과와 관련이 있습니다. 제조업체는 문제를 해결했다고 믿으며 FDA의 재검사를 기다리고 있습니다. 레제너론은 린보셀타맙을 신속하게 시장에 출시하기 위해 제조업체 및 FDA와 협력할 것을 다짐하고 있습니다. 유럽 의약품청(EMA)는 동일한 적응증에 대해 여전히 린보셀타맙을 검토 중입니다. 이 업데이트는 대부분의 다발성 골수종 환자들이 재발하며 말기 치료에서 추가 요법이 필요하기 때문에 중요합니다.
Regeneron Pharmaceuticals (NASDAQ: REGN) a reçu une Lettre de Réponse Complète (CRL) de la FDA pour sa Demande de Licence Biologique (BLA) pour linvoseltamab, un traitement du myélome multiple en rechute/réfractaire. La CRL était attendue et concerne les constatations d'inspection faites chez un fabricant tiers de remplissage/finition. Le fabricant estime que les problèmes ont été résolus et attend une nouvelle inspection de la FDA. Regeneron s'engage à collaborer avec le fabricant et la FDA afin d'introduire rapidement linvoseltamab sur le marché. L'Agence Européenne des Médicaments (EMA) examine toujours linvoseltamab pour la même indication. Cette mise à jour est importante car la plupart des patients atteints de myélome multiple rechutent et nécessitent des thérapies supplémentaires dans les phases avancées.
Regeneron Pharmaceuticals (NASDAQ: REGN) hat von der FDA einen Complete Response Letter (CRL) für seinen Antrag auf Biologika-Lizenz (BLA) für linvoseltamab erhalten, einem Medikament zur Behandlung von rezidivierenden/refraktären multiples Myelom. Der CRL war vorhersehbar und bezieht sich auf Inspektionsergebnisse eines Drittanbieter-Füll-/Fertigungsunternehmens. Der Hersteller glaubt, dass die Probleme behoben wurden und wartet auf eine erneute Inspektion durch die FDA. Regeneron verpflichtet sich, mit dem Hersteller und der FDA zusammenzuarbeiten, um linvoseltamab schnell auf den Markt zu bringen. Die Europäische Arzneimittel-Agentur (EMA) prüft linvoseltamab weiterhin für dieselbe Indikation. Dieses Update ist wichtig, da die meisten Patienten mit multiplem Myelom rezidivieren und in fortgeschrittenen Phasen zusätzliche Therapien benötigen.
- Anticipated outcome, previously disclosed during Q2 2024 earnings call
- Third-party manufacturer believes inspection findings have been resolved
- FDA reinspection expected in the coming months
- Regulatory review ongoing by European Medicines Agency (EMA)
- FDA issued Complete Response Letter (CRL) for linvoseltamab BLA
- Delay in potential approval due to third-party manufacturer inspection findings
- Uncertainty regarding timeline for FDA reinspection and potential approval
Insights
The FDA's Complete Response Letter (CRL) for linvoseltamab is a temporary setback for Regeneron in the competitive multiple myeloma (MM) space. While the issue is not related to the drug's efficacy or safety, it highlights the critical importance of manufacturing processes in biologics approval. The delay could impact Regeneron's market entry timing, potentially affecting its competitive position against other late-line MM treatments.
From a clinical perspective, linvoseltamab's development for relapsed/refractory MM patients who have progressed after at least three prior therapies addresses a significant unmet need. The high relapse rate in MM underscores the importance of new treatment options. The ongoing EMA review suggests confidence in the drug's potential, but the FDA's decision may influence global regulatory strategies.
Investors should monitor the timeline for the third-party manufacturer's reinspection, as this will be important for determining linvoseltamab's potential approval date and Regeneron's ability to capitalize on the late-line MM market opportunity.
The CRL for linvoseltamab highlights the complex regulatory landscape for biologics. The issue stemming from a third-party manufacturer underscores the FDA's stringent oversight of the entire supply chain, not just the drug developer. This scenario is not uncommon in the industry and typically results in delays rather than outright rejections.
Regeneron's proactive disclosure of this anticipated outcome during their Q2 earnings call demonstrates transparency with investors. The company's commitment to working closely with both the manufacturer and the FDA suggests a clear path forward, albeit with an uncertain timeline.
The ongoing EMA review adds an interesting dynamic, as regulatory decisions can sometimes influence each other across jurisdictions. Investors should watch for any divergence in outcomes between the FDA and EMA, which could impact Regeneron's global commercialization strategy for linvoseltamab.
The CRL for linvoseltamab presents a mixed financial outlook for Regeneron. While the delay in potential approval could impact near-term revenue projections, the issue appears resolvable, preserving the drug's long-term market potential. Investors should consider the following financial implications:
- Potential delay in revenue generation from linvoseltamab
- Possible increase in R&D expenses to address regulatory requirements
- Impact on market share in the competitive MM space due to delayed entry
However, Regeneron's diversified portfolio and strong financial position (
Investors should monitor for updates on the reinspection timeline and any revisions to Regeneron's financial guidance in light of this development.
TARRYTOWN, N.Y., Aug. 20, 2024 (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) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. This anticipated outcome was previously disclosed during Regeneron’s second quarter 2024 earnings call.
The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate. The third-party fill/finish manufacturer has since informed Regeneron that it believes the findings have been resolved, their facility is awaiting reinspection by the FDA, and it is expected to take place in the coming months.
Regeneron is committed to working closely with the third-party fill/finish manufacturer and the FDA to bring linvoseltamab to appropriate patients with R/R MM as quickly as possible, which is critical because most MM patients relapse and ultimately require additional therapies in late-line settings.
Regulatory review of linvoseltamab remains ongoing by the European Medicines Agency (EMA) in the same indication. Linvoseltamab is investigational, and its safety and efficacy have not been approved by any regulatory authority.
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 linvoseltamab; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates (such as linvoseltamab, including any potential regulatory approval of linvoseltamab by the U.S. Food and Drug Administration (the “FDA”) based on the Biologics License Application discussed in this press release (the “linvoseltamab BLA”) or the regulatory review by the European Medicines Agency referenced in this press release) and new indications for Regeneron’s Products; the impact of the Complete Response Letter for the linvoseltamab BLA discussed in this press release (the “CRL”) on the timing of the potential regulatory approval of linvoseltamab by the FDA and whether and how timely Regeneron and/or the third-party fill/finish manufacturer are able to resolve the issues identified in the CRL; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates (such as linvoseltamab) and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) (including the third-party fill/finish manufacturer referenced in this press release) 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 and Regeneron’s Product Candidates (such as linvoseltamab) 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; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; 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 (such as the COVID-19 pandemic) on Regeneron's business; and 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), other litigation and other proceedings and government investigations relating to the Company and/or its operations, 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, 2023 and its Form 10-Q for the quarterly period ended June 30, 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 Tammy Allen Tel: +1 914-306-2698 tammy.allen@regeneron.com | Investor Relations Vesna Tosic Tel: +1 914-847-5443 vesna.tosic@regeneron.com |
FAQ
What is the current status of Regeneron's linvoseltamab BLA for multiple myeloma?
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