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Gilead HCV combo granted speedy EU assessment

This article was originally published in Scrip

Executive Summary

Gilead Sciences' once-daily, fixed dose combination of ledipasvir and sofosbuvir has been granted accelerated assessment by the European Medicines Agency, following the company's Marketing Authorisation Application (MAA) in February. The speeded up process could shorten the review time by about two months. The hepatitis C treatment, if approved, could therefore be available in the EU by the end of 2014.

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