Leonard Schleifer, Regeneron CEO (Lev Radin/Sipa USA/Sipa via AP Images)

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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.