FDA Issues Complete Response Letter For Aflibercept 8mg Biologics License Application Solely Due To An Ongoing Review Of Inspection Findings At A Third-Party Filler
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The FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8 mg, a drug being jointly developed by Regeneron Pharmaceuticals and Bayer AG. The CRL is due to an ongoing review of inspection findings at a third-party filler and does not identify any issues with the drug's clinical efficacy or safety. No additional clinical data or trials have been requested. Regulatory filings for aflibercept 8 mg are under review in Europe and Japan.
June 27, 2023 | 6:57 pm
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Regeneron's drug aflibercept 8 mg, developed in partnership with Bayer, has received a CRL from the FDA due to inspection findings at a third-party filler. No issues with the drug's efficacy or safety were identified.
The FDA's CRL is related to inspection findings at a third-party filler, not the drug itself. This suggests that the issue may be resolved without affecting the drug's approval process significantly. However, it may cause some delay in the drug's approval and launch, potentially impacting Regeneron's short-term revenues.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100