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.”
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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