The US Food and Drug Administration (FDA) has declined to approve ’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site. The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution.
The gold standard of business intelligence. Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release.
Regeneron submitted the biologics licence application (BLA) for linvoseltamab in February this year. The European Medicines Agency (EMA) is in the same indication, and the application to the EMA was also accepted in February. The agency typically takes up to 210 days to evaluate a marketing authorisation.
An investigational bispecific antibody, linvoseltamab, is aimed at adults with relapsed/refractory multiple myeloma who have undergone treatment with a minimum of three previous therapies. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
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