Regeneron Updates Biologics License Application for Linvoseltamab

On August 20, 2024, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) disclosed that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) concerning the Biologics License Application (BLA) for linvoseltamab. This drug is intended for patients with relapsed/refractory (R/R) multiple myeloma (MM) who have already undergone at least three prior therapies. This development was anticipated as it had been previously mentioned during Regeneron’s second quarter 2024 earnings call.

The CRL identified a single approvability issue linked to findings from a pre-approval inspection at a third-party fill/finish manufacturer, which was producing a different company's product candidate. This manufacturing partner has since informed Regeneron that they believe the issues have been resolved. The facility is now awaiting reinspection by the FDA, which is expected to happen in the coming months.

Regeneron emphasizes its commitment to collaborating closely with the third-party fill/finish manufacturer and the FDA to expedite the availability of linvoseltamab for patients with R/R MM. This effort is critical because most multiple myeloma patients experience relapses and eventually need additional treatments in later stages of the disease.

In addition to the ongoing regulatory review in the U.S., the European Medicines Agency (EMA) is also evaluating linvoseltamab for the same condition. Currently, linvoseltamab remains an investigational drug, and its safety and efficacy have yet to receive approval from any regulatory authority.

Regeneron Pharmaceuticals is a prominent biotechnology company dedicated to inventing, developing, and commercializing transformative medicines for serious diseases. Established and led by physician-scientists, Regeneron has a consistent track record of translating scientific discoveries into approved treatments and promising product candidates. Most of these developments have originated from their in-house laboratories. The company's medicinal portfolio and pipeline aim to address a wide range of conditions, including eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic disorders, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron is at the forefront of scientific innovation and accelerates drug development through proprietary technologies like VelociSuite®. This technology enables the production of optimized fully human antibodies and novel classes of bispecific antibodies. The company is advancing the next generation of medicine with data-driven insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms. These efforts allow Regeneron to identify new targets and complementary methods that could potentially treat or even cure various diseases.