Regeneron, Sanofi Get Positive CHMP Opinion for Dupixent

By Chris Wack

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Dupixent dupilumab in a third indication.

The companies said CHMP recommended Dupixent be approved as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis for whom therapy with systemic corticosteroids and/or surgery don't provide adequate disease control.

If approved, Dupixent would be the first biologic medicine available in the European Union to treat these patients.

Regeneron and Sanofi said the positive CHMP opinion is based on two pivotal Phase 3 trials that evaluated Dupixent 300 mg every two weeks plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids. A final decision on the Dupixent application by the European Commission is expected in the coming months.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

September 20, 2019 07:07 ET (11:07 GMT)

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