Sanofi, Regeneron’s Dupixent drug gets positive opinion from CHMP

Sanofi, Regeneron’s Dupixent drug gets positive opinion from CHMP

7:02 AM, 24th September 2019
Sanofi, Regeneron logo

PARIS, FRANCE/TARRYTOWN, US: Sanofi and Regeneron announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab) in a third indication.

Dupixent is used to treat people with nasal polyps. The 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 (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. 

The company said that if approved, Dupixent would be the first biologic medicine available in the European Union (EU) to treat these patients.

The positive CHMP opinion is based on two pivotal Phase 3 trials (the 24-week SINUS-24 and 52-week SINUS-52) 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.

Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in CRSwNP, asthma and atopic dermatitis.

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. For patients with severe CRSwNP, the current standard-of-care includes intermittent courses of systemic corticosteroids or sinonasal surgery, both of which are associated with disease recurrence.

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