FDA asks for more data on Dupixent in COPD in move that could delay a decision

The FDA wants more in­fo on Re­gen­eron and Sanofi’s block­buster Dupix­ent be­fore it de­cides whether to ap­prove the treat­ment for some pa­tients with chron­ic ob­struc­tive pul­monary dis­ease, or COPD.

That re­quest could de­lay a de­ci­sion by three months.

Ear­li­er this week, the agency re­quest­ed more ef­fi­ca­cy analy­ses on sub­pop­u­la­tions from two Phase 3 tri­als sub­mit­ted as part of the ap­pli­ca­tion pack­age, Re­gen­eron CEO Leonard Schleifer said Thurs­day on the com­pa­ny’s quar­ter­ly earn­ings call.

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