European Medicines Agency has validated its MAA for new Gilead’s pill for Hepatitis C treatment
Gilead Sciences, Inc. announced this Friday that the company’s Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated and is now under assessment by the European Medicines Agency (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.
Gilead also submitted a New Drug Application to the U.S. Food and Drug Administration for SOF/VEL/VOX on December 8, 2016.
“Direct-acting antiviral treatments have transformed our ability to treat hepatitis C; however, for some patients who have failed to achieve a cure with these regimens, effective and well-tolerated therapies are still needed. The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-acting antiviral therapy, in Europe and around the world,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead.