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Regeneron, Sanofi Withdraw FDA Application For Libtayo's Expanded Use

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Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and its partner Sanofi SA (NASDAQ: SNY) have voluntarily withdrawn their application with the FDA for the expanded use of Libtayo in patients with advanced cervical cancer.

  • The application for the monoclonal antibody as the second-line of treatment in the patients was withdrawn "after the companies and the FDA were not able to align on certain post-marketing studies."

  • The FDA had accepted the supplemental application for priority review in September, with the target action date for the decision on January 30, 2022.

  • Related: Sanofi, Regeneron, Share Competitive Libtayo Survival Data in 1L NSCLC.

  • Regeneron and Sanofi are still discussing marketing applications with regulatory authorities outside the U.S, the companies said.

  • Related content: Benzinga's Full FDA Calendar.

  • The drug is already approved for some types of skin and lung cancer.

  • Price Action: REGN stock is down 0.43% at $606.09, and SNY is lower by 0.93% at $52.37 on the last check Friday.

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