The FDA has approved an expanded use of Gilead Sciences' (NASDAQ:GILD) pediatric indication of Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV genotype or liver disease severity.
Gilead has announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for patients as young as six for the treatment of chronic hepatitis C.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment of people with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity. The recommended dosage of Epclusa in children ages 6 years and older is based on weight and liver function. Epclusa is the first pan-genotypic, protease inhibitor-free regimen approved in the United States for adults and children.
Gilead Sciences isn't letting a few of its own generics interfere with advertising its pan-genotypic hep C drug Epclusa. The Big Biotech is turning to TV again to promote its hep C franchise, this time with a commercial that highlights Epclusa's versatility across different strains of the disease.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 8, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), a once-daily treatment for adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis, and for patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral therapy (DAA).
AbbVie`s latest hep C push highlights Mavyret`s time-to-cure advantage
Hookipa Biotech, based in Vienna, and Gilead, headquartered in Foster City, California, inked a research collaboration deal to develop and commercialize therapeutics for hepatitis B (HBV) and HIV.