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Gilead’s universal hep C therapy Epclusa approved in EU

European nod for first pan-genotypic treatment follows recent FDA licensing

Gilead Sciences Epclusa sofobuvir velpatasvirGilead's pan-genotypic hepatitis C virus (HCV) treatment Epclusa has been granted marketing authorisation following an accelerated review procedure by the European Commission.

The EU regulatory authority approved the therapy to treat adult patients with chronic HCV across all six major forms with and without cirrhosis - the first single tablet regimen of its kind.

It adds another Sovaldi-based treatment to Gilead's HCV stable, combining the blockbuster drug with velpatasvir in a once-daily, typically ribavirin-free dosage.

John Milligan, president and chief executive officer of Gilead, said that the European licence “reflects our continued focus to bring a cure to all infected patients across the region”.

He added that the pharma firm will work with physicians, healthcare providers and governments in Europe to make Epclusa available to patients as quickly as possible.

The universal HCV treatment has already been granted approval in the US, with the FDA authorizing its licence application at the end of June.

Both approvals were based on four clinical trials, which showed that 98% of patients without cirrhosis or with mild cirrhosis treated with Epclusa had no evidence of the virus in the blood after 12 weeks of treatment.

Commenting on the verdict, Prof William Rosenberg, clinical lead for viral hepatits at UCL's Institute for Liver and Digestive Health, said that Epclusa “marks an important advance in the treatment of HCV and is a new step in our efforts to achieve elimination”.

Gilead's latest HCV therapy pipped rival drug Zepatier (elbasvir/grazoprevir) to the post for EU marketing authorisation, with Merck & Co. still awaiting approval from the EMA committee.

The competition is already underway in the US however, as Zepatier received FDA approval in January this year, allowing the firm to market the drug for HCV genotypes 1 and 4.

Article by
Rebecca Clifford

21st July 2016

From: Regulatory



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