PARIS (dpa-AFX) - The U.S. Food and Drug Administration has extended by
three months the target action date of its priority review of the supplemental
Biologics License Application or sBLA for Dupixent (dupilumab) as an add-on
maintenance treatment in certain adult patients with uncontrolled chronic
obstructive pulmonary disease or COPD, Regeneron Pharmaceuticals Inc (REGN) and
Sanofi said in a statement.

The revised target action date is September 27, 2024. The FDA did not raise any
concerns regarding the approvability of Dupixent for this indication.

The FDA had requested additional analyses on the efficacy of Dupixent in the
BOREAS and NOTUS pivotal trials. Based on the submission of these analyses
earlier in May, the agency has now determined that this additional information
constituted a major amendment to the sBLA and extended the target action date
accordingly.

Regeneron and Sanofi said they are confident that the additional analyses
strongly support the approval of Dupixent in COPD with evidence of type 2
inflammation.

Additionally, submissions for Dupixent in COPD are currently under review with
regulatory authorities around the world, including the European Union and China.
Recently, the European Medicines Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP) adopted a positive opinion and recommended the approval of
Dupixent as an add-on maintenance treatment in adults with uncontrolled COPD
characterized by raised blood eosinophils.

The potential use of Dupixent in COPD is currently under clinical development,
and the safety and efficacy have not been fully evaluated by any regulatory
authority.

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