FOSTER CITY (dpa-AFX) - Gilead Sciences, Inc. (GILD) announced Friday that the European Medicines Agency has validated its Marketing Authorization Application or MAA for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX).
The MAA for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) is for the treatment of chronic hepatitis C virus (HCV)-infected patients. It is now under assessment by the EMA.
The MAA for SOF/VEL/VOX is supported by data from two Phase 3 studies. The MAA also includes data from two additional phase 3 studies.
SOF/VEL/VOX for the treatment of HCV will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway and Iceland. The review will follow an accelerated procedure reserved for medicinal products expected to be of major public health interest.
Gilead also submitted a New Drug Application to the U.S. Food and Drug Administration for SOF/VEL/VOX on December 8, 2016.
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