FDA extends deadline, requests more data on Sanofi’s Dupixent for treating ‘smoker’s lung’

By Thomson Reuters May 31, 2024 | 12:31 AM

(Reuters) – French drugmaker Sanofi and its partner Regeneron said on Friday the U.S. Food and Drug Administration (FDA) requested additional analyses on the efficacy of Dupixent as an add-on treatment in certain patients ‘smoker’s lung’, or COPD.

As a result, the deadline for the review was pushed back by three months, to September 27.

Sanofi last year said it would seek U.S. approval for its anti-inflammatory drug Dupixent for COPD after a second large trial showed significant benefits in a bid to widen the market of its blockbuster drug.

“The FDA had requested additional efficacy analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials,” Sanofi said on Friday, adding it was still “confident” the approval would come “as quickly as possible.”

In a separate release, Sanofi said EU drug authority CHMP gave a positive recommendation on the approval of Dupixent in Europe as an add-on maintenance treatment for COPD characterized by raised blood eosinophils.

The EU Commission usually follows the guidance from the CHMP.

(Reporting by Diana Mandiá, editing by Tassilo Hummel)