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Gilead Sciences receives CHMP positive opinion for DAA Vosevi
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Gilead Sciences announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the company’s Marketing Authorization Application for its direct-acting antiviral regimen sofosbuvir-velpatasvir-voxilaprevir, or Vosevi, according to a press release.
The application for Vosevi includes data from four phase 3 studies that support its safe use in patients with hepatitis C genotypes 1 through 6, with or without compensated cirrhosis, regardless of prior therapy. The recommended regimens are 8 weeks of treatment in DAA-naive patients and 12 weeks for those who have previously failed DAA therapy.
Following the positive opinion from CHMP, the European Commission will review the recommendation for approval in the 28 European Union countries, Norway and Iceland.
Additionally, Gilead Sciences submitted a new drug application for Vosevi to the FDA on Dec. 8, 2016. The FDA set a target action date under the Prescription Drug User Fee Act for Aug. 8, 2017.
References: www.gilead.com