gilead-sciences

Gilead says US FDA approves Epclusa to treat hepatitis C

pharmafile | June 29, 2016 | News story | Research and Development, Sales and Marketing Epclusa, Gilead, HCV, US FDA, drug approval, regulation 

US drug firm Gilead Sciences (Nasdaq: GILD) said the US Food and Drug Administration has approved its Epclusa (sofosbuvir/velpatasvir), in combination with ribavirin, to treat hepatitis C virus (HCV) infection.

The company said the drug is also the first single-tablet regimen authorised for the treatment of HCV genotype 2 and 3 infection without ribavirin.

Gilead’s Chief Executive John Milligan, said: “As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.”

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The approval was backed by efficacy and safety data from Phase III trials in HCV-infected patients with and without cirrhosis, the company said in a statement.

Gilead has set a price of $74 760 for a 12-week course of treatment for Epclusa, compared with a list price of $84 000 for Sovaldi and $94 500 for Harvoni.

Anjali Shukla

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