EU body recommends approval of Gilead's hepatitis C combination therapy Harvoni

Gilead Sciences announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CMHP) adopted a positive opinion related to a marketing application for Harvoni (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults. The company noted that the CHMP's decision was made after an accelerated review procedure.

The once-daily oral drug is a fixed-dose combination of the NS5A inhibitor ledipasvir and the nucleotide analogue polymerase inhibitor sofosbuvir, which was approved as a single agent by the European Commission in January and is marketed as Sovaldi. Gilead said the latest decision is supported by data from the late-stage ION-1, ION-2 and ION-3 studies, which evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2000 genotype 1 HCV patients with compensated liver disease. The studies included cirrhotic and non-cirrhotic patients who were new to HCV treatment and those who had failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.

Gilead added that the CHMP's opinion was also supported by preliminary data from the SOLAR-1 trial in decompensated cirrhotic and pre- and post-transplant patients, as well as the ELECTRON-2 trial in genotype 3 patients and Phase II studies in genotype 4 patients.

A marketing application for the combination of ledipasvir and Sovaldi is under review in the US, while Gilead recently submitted a filing in Japan.

Sales of Sovaldi reached $3.5 billion in the second quarter, beating analyst estimates, while the product amassed first-half revenue of $5.8 billion.

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