Sovaldi OK’d for marketing throughout European Union

The European Commission granted marketing authorization to Gilead Sciences for once-daily Sovaldi with ribavirin and/or interferon for treatment of adults with chronic hepatitis C, according to a company news release.

The authorization, following an accelerated assessment by the European Medicines Agency, allows for Sovaldi (sofosbuvir), an oral nucleotide analog polymerase inhibitor, to be marketed in all 28 EU nations, the release said.

“We are committed to working with local governments and health systems to make Sovaldi available in Europe as quickly as possible,” John C. Martin, PhD, chairman and CEO of Gilead, said in the release.

The approval covers use of Sovaldi with ribavirin or with ribavirin and pegylated interferon for 12 to 24 weeks among HCV patients with genotypes 1-6 and for use with ribavirin until liver transplantation for HCV patients awaiting transplant, the release said. Monotherapy is not recommended.

EU authorization was largely based on data from a series of phase 3 studies — NEUTRINO, FISSION, POSITRON and FUSION — in which Sovaldi-based therapy was deemed superior or noninferior to standard HCV treatment, according to the release. Trial patients demonstrated sustained virologic response 12 weeks after end of treatment in 50% to 90% of cases.

Sovaldi gained approval in the United States and Canada in December, and applications are pending in Australia, New Zealand, Switzerland and Turkey, the release said.