EU committee backs approval of Gilead Sciences' HCV drug Sovaldi

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday adopted a positive opinion recommending approval of Gilead Sciences' Sovaldi (sofosbuvir) for the treatment of hepatitis C virus (HCV) infection in combination with other agents. Gilead said that, if approved, the once-daily oral nucleotide analogue polymerase inhibitor could be available in the EU as early as the first quarter of next year .

Gilead's marketing authorisation application for the therapy was supported by data from four Phase III trials in which HCV-infected patients were treated with Sovaldi in combination with other therapies such as ribavirin for 12 weeks or 16 weeks. In the late-stage studies, Sovaldi was demonstrated to be superior or non-inferior to currently available HCV therapies, as assessed by the proportion of patients who experienced a sustained virologic response after 12 weeks of treatment.

RBC Capital Markets analyst Michael Yee indicated that the decision by the CHMP was rendered at least a month earlier than expected. "We think they'll do $2 billion in the US alone, and EU could add a few hundred million as its country-by-country launch in EU starting primarily with Germany and other countries can take up to 6-12 months for full reimbursement/pricing and distribution launch," Yee commented.

The medicine also received a positive review from an FDA advisory panel last month, with a final decision by the US regulator expected by December 8.

For related analysis read ViewPoints: Regulatory momentum builds for Gilead Sciences' sofosbuvir – now branded as Sovaldi.

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