Regeneron Updates on Biologics License Application for Linvoseltamab
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for linvoseltamab, which is intended for patients with relapsed/refractory (R/R) multiple myeloma (MM) who have not responded to at least three previous therapies. This news was shared during Regeneron’s earnings call for the second quarter of 2024.
The only issue affecting approval stems from findings during a pre-approval inspection at a third-party fill/finish manufacturer associated with another company's product candidate. The manufacturer has communicated to Regeneron that it believes these findings have been addressed, and they are currently awaiting a reinspection by the FDA, which is anticipated to occur in the coming months.
Regeneron is dedicated to collaborating closely with both the third-party fill/finish manufacturer and the FDA to ensure linvoseltamab is made available to patients with R/R MM as swiftly as possible. This is particularly important since most MM patients experience relapses and eventually require additional therapies in later treatment lines.
Regulatory Review Status
The European Medicines Agency (EMA) is also conducting an ongoing regulatory review of linvoseltamab for the same indication. It’s important to note that linvoseltamab is still investigational, and its safety and efficacy have not yet been approved by any regulatory body.
About Regeneron
Regeneron (NASDAQ: REGN) is a prominent biotechnology company focused on inventing, developing, and commercializing transformative medicines for individuals facing serious health challenges. Founded and led by physician-scientists, our unique capability to translate scientific discoveries into effective treatments has resulted in numerous approved therapies and a robust pipeline of product candidates, many of which originated in our own laboratories. Our medicines and development pipeline aim to assist patients suffering from a variety of conditions, including eye diseases, cancer, cardiovascular and metabolic disorders, as well as rare diseases.
Innovations in Science and Drug Development
At Regeneron, we are committed to pushing the boundaries of scientific research and expediting drug development through proprietary technologies like VelociSuite, which allows us to produce optimized fully human antibodies and bispecific antibodies. We are at the forefront of medicine, leveraging data-driven insights from the Regeneron Genetics Center and pioneering genetic medicine platforms to identify innovative targets that could potentially treat or cure diseases.
Contact Information
Media Relations
Tammy Allen
Tel: +1 914-306-2698
Email: tammy.allen@regeneron.com
Investor Relations
Vesna Tosic
Tel: +1 914-847-5443
Email: vesna.tosic@regeneron.com
Frequently Asked Questions
What is the latest update on linvoseltamab's BLA?
Regeneron has received a Complete Response Letter (CRL) from the FDA concerning the BLA for linvoseltamab.
What prompted the Complete Response Letter?
The CRL was issued due to findings from a pre-approval inspection at a third-party fill/finish manufacturer.
What actions is Regeneron planning to take next?
Regeneron is actively collaborating with the third-party manufacturer and the FDA to address the issues and expedite the approval process.
Is linvoseltamab undergoing review by any other regulatory agencies?
Yes, the European Medicines Agency (EMA) is also reviewing linvoseltamab for the same indication.
What is Regeneron's core mission?
Regeneron is dedicated to inventing, developing, and commercializing life-changing medicines for individuals with serious diseases through innovative scientific approaches and technologies.
