EMA advisory unit issues bunch of positive recommendations

At its late November meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a series of recommendation, including positive opinions for the approval of five new drugs.

First, the CHMP recommended granting a marketing authorization for Gilead Sciences (Nasdaq: GILD) Sovaldi (sofosbuvir) in combination with other medicines for the treatment of chronic (long-term) hepatitis C in adults.

The CHMP opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of major public health interest. This assessment does not guarantee marketing authorization by the European Commission. However, if approved, Sovaldi could be available in the EU in the first quarter of 2014, according to Gilead, which noted that, in the USA, an expert advisory committee of the Food and Drug Administration voted unanimously (15-0) on October 25 that the available data support approval of sofosbuvir. A final decision from the FDA is anticipated by December 8, 2013.

Backs ViiV’s Tivicay