Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the Nasdaq (NASDAQ: REGN), has encountered a setback in its pursuit of market approval for the bispecific antibody (BsAb) linvoseltamab. The US FDA has issued a Complete Response Letter (CRL) regarding the company’s filing for this innovative treatment, which targets the B cell maturation antigen (BCMA) and CD3 for the treatment of relapsed/refractory multiple myeloma (MM) as a fourth-line or later option.
In a statement released by Regeneron, the company highlighted that the sole obstacle to approval is a matter identified during a pre-approval inspection at a third-party fill/finish manufacturing facility. Regeneron has indicated that the third-party manufacturer has not only recognized the issue but has also taken corrective actions to resolve it. The company is now in a period of anticipation for the FDA’s reinspection, which is projected to occur within the upcoming months.- Flcube.com
