Gilead: Marketing Authorization Application for Ledipasvir/Sofosbuvir Is Under EMA Review

Gilead Sciences said Thursday that its marketing authorization application for a once-daily fixed-dose ledipasvir 90 mg/sofosbuvir 400 mg combination for genotype 1 hepatitis C has been validated by the European Medicines Agency and is being reviewed.

The application is based on data from three Phase III studies with close to 2,000 genotype-1 HCV patients who were treatment-naïve, had failed previous treatment or had compensated cirrhosis. The patients were randomized to ledipasvir/sofosbuvir with or without ribavirin for eight, 12 or 24 weeks.

“Based on the results of the Phase III ION studies, LDV/SOF has the potential to transform HCV therapy for genotype 1 patients by eliminating the need for interferon injections and ribavirin and reducing the duration of treatment,” said Norbert Bischofberger, Gilead’s chief scientific officer.

The EMA has granted accelerated assessment for the combination product, potentially shaving two months off the review time. This would make LDV/SOF available in the EU by the end of this year, Gilead said. Applications in the U.S. and Canada are pending.

Sofosbuvir was approved in the EU as a single agent in January and in the U.S. in December. House Democrats earlier this month requested that Gilead justify the drug’s $84,000-per-course price tag, expressing concerns that low-income and minority patients may not be able to afford it. The monotherapy also is approved in the UK, Canada, New Zealand, Switzerland, France, Finland, Sweden, Austria, Ireland and Germany.

Meanwhile, Sovaldi is facing patent infringement suits from AbbVie, Idenix, Roche and Merck over its drug. — Lena Freund

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