logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Amazon said it will convert 125,000 of the 175,000 temporary workers it hired in March amid the coronavirus pandemic, to permanent full-time employees in June. The e-commerce giant had hired the temporary employees in March to meet strong consumer demand amid the lockdown. The job openings were in Amazon's fulfillment centers and its delivery network. Mitsubishi Motors North America inc. recalled 141,200 cars and sports utility vehicles (SUVs) due to potential corrosion of the front cross member because of salt water exposure such as from road salt use in cold-weather, according to the National Highway Traffic Safety Administration. The recall is expected to begin on July 14, 2020. The U.S. State of Arizona filed a consumer fraud lawsuit against Google alleging deceptive and unfair practices used to obtain users' location data. In the filing, Arizona Attorney General Mark Brnovich accused that the tech giant exploits these data for its lucrative advertising business. In a tweet, Brnovich said, "We brought forward this action to put a stop to Google's deceptive collection ...
Follow RTT