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.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER