Analysts are predicting Gilead Sciences’ hepatitis C drug Sovaldi will reach blockbuster status before the year’s end, estimating U.S. sales of about $3 billion following news of its approval in the EU Friday.
FDA approval of Sovaldi (sofosbuvir) came Dec. 6, 2013, applicable to patients with genotypes 2-6, while the European Commission approved 400 mg tablets of the drug for all six genotypes of the disease. In December, however, Gilead announced Phase III data showed that patients with genotype 1 — the most prevalent form of hepatitis C in the U.S. — showed overwhelming response rates to the drug after 8, 12 and 24 weeks of treatment. The Foster City, Calif.-based drugmaker plans to submit an NDA for Sovaldi with ledipasvir early this year.
The EC’s decision was based primarily on results of four Phase III studies showing that patients given Sovaldi had undetectable levels of the virus after 12 weeks of treatment. Fifty to 90 percent of patients reached this point, at which they are considered cured of hepatitis C.
Sovaldi has been approved in Canada. Applications are still out in Australia, New Zealand, Switzerland and Turkey. — Lena Freund
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