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Regeneron And Sanofi Say CHMP Adopts Positive Opinion For Dupixent

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said that the European Medicines Agency's Committee for Medicinal Products for Human Use or 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 or CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

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

CHMP has adopted a positive opinion for Dupixent or dupilumab in a third indication.

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 (EC) is expected in the coming months.

CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages. It can lead to persistent breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure or pain.

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