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.