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FDA extends deadline, requests more data on Sanofi's Dupixent for treating 'smoker's lung'
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FDA extends deadline, requests more data on Sanofi's Dupixent for treating 'smoker's lung'
May 30, 2024 10:47 PM

May 31 (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.

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