EU regulator clears Gilead Sciences' hepatitis C therapy Sovaldi

Gilead Sciences announced Friday that the European Commission approved Sovaldi (sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults, in combination with ribavirin and pegylated interferon alpha. The authorisation follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in November last year.

According to the company, Sovaldi has been approved for use in patients with genotypes 1-6 HCV and is the first all-oral treatment option for patients who cannot take interferon. The drugmaker added that the clearance marks the first regimen for patients awaiting liver transplantation to prevent HCV recurrence. Gilead CEO John Martin said "we are committed to working with local governments and health systems to make Sovaldi available in Europe as quickly as possible."

Approval of the once-daily oral nucleotide analogue polymerase inhibitor was based on results from the NEUTRINO, FISSION, POSITRON and FUSION Phase III studies, in which 12 or 16 weeks of Sovaldi-based therapy was found to be superior or non-inferior compared with currently available treatment options. In the trials, patients experienced sustained virologic response at 12 weeks (SVR12) rates of 50 percent to 90 percent.

Gilead noted that during the review, data from the VALENCE and PHOTON-1 late-stage studies were added to the marketing application. In the VALENCE study, patients with genotype 3 HCV infection were treated with Sovaldi and ribavirin for 24 weeks. Meanwhile, the PHOTON-1 study assessed the efficacy of treatment with Sovaldi and ribavirin for 12 weeks in patients co-infected with genotype 2 or 3 HCV and HIV, and for 24 weeks in patients with genotype 1 HCV and HIV co-infection. Gilead noted that viral resistance was not identified in any patient who experienced a relapse following the completion of treatment.

Sovaldi was approved in the US and Canada in December last year (for related analysis, read ViewPoints: Gilead Sciences' Sovaldi hits the ground running). Marketing applications are also under review in Australia, New Zealand, Switzerland and Turkey.

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