FDA says children as young as age 3 years can take Epclusa for hepatitis C

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Sumary of FDA says children as young as age 3 years can take Epclusa for hepatitis C:

  • The FDA originally approved Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) for adults in 2016 and for children aged 6 years or older in March 2020..
  • Gilead said the FDA has approved two strengths of an oral pellet — sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg — that were developed for younger children who cannot swallow tablets..
  • “This approval adds to the robust clinical evidence supporting the safety and ecacy of Epclusa across a broad set of patients, including those with end-stage.”…

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