PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the approval of Dupixent in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. The positive CHMP opinion is supported by data from two Phase 3 trials, PRIME and PRIME2, the companies noted.
The European Commission is anticipated to announce a final decision on the Dupixent application in the coming months.
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