Gilead receives EU approval for combo hepatitis C treatment
pharmafile | July 11, 2016 | News story | Sales and Marketing | Epclusa, Gilead, eu approval, sofosbuvir
Gilead Sciences (NASDAQ: GILD) has received a marketing authorisation approval from the European Commission for combination treatment Epclusa (sofosbuvir/velpatasvir) for patients with all genotypes of chronic hepatitis C.
This latest approval comes following the US Food and Drug Administration’s (FDA) decision to approve Epclusa just two weeks ago.
The company calls Epclusa the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus infection. The 12-week combo treatment has been authorised for use in patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin for patients with decompensated cirrhosis.
Furthermore, Epclusa is also the first single tablet regimen approved for the treatment of patients with genotype 2 and 3 of the virus, without the need for ribavirin. It is the latest combination drug regimen to feature blockbuster drug Sovaldi (sofosbuvir), after Harvoni (sofosbuvir/ledipasvir) received EU marketing authorisation approval in late-2014. To date, over one million people have been prescribed a sofosbuvir-based regimen.
In Phase III trials, between 83-94% of patients receiving some form of the combination drug achieved a sustained viral response rate 12 weeks after treatment. Lead study investigator, Professor Stefan Zeuzem, comments: “Built on the foundation of sofosbuvir, [Epclusa] offers a highly effective and tolerable choice which is protease inhibitor free and ribavirin free for the majority of patients. For the first time we have a once-daily single tablet treatment option which works across all genotypes including genotype 3, which is often the least responsive to treatment.”
John Milligan, CEO at Gilead, says: “The European approval of [Epclusa] reflects our continued focus to bring a cure to all infected patients across the region and we look forward to working with physicians, healthcare providers and governments to make it available as quickly as possible.”
Sean Murray
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