(RTTNews) - Gilead Sciences Inc. (GILD) said that the U.S. Food and Drug Administration has approved new formulation of Epclusa, expanding pediatric indication to treat children ages 3 and older with Chronic Hepatitis C.
The company noted that the new oral pellet formulation enables treatment in early childhood with pangenotypic, panfibrotic regimen.
The FDA approved a New Drug Application for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children ages 3 years and older is based on weight.
Treatment with Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin for patients with decompensated cirrhosis (Child-Pugh B or C). Sofosbuvir/velpatasvir is the only protease inhibitor-free, pangenotypic HCV regimen approved for patients as young as 3 years of age.
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