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Reuters Health Information (2013-11-25): Drugs for HCV, HIV, diabetes recommended for approval in EU

Regulatory

Drugs for HCV, HIV, diabetes recommended for approval in EU

Last Updated: 2013-11-25 19:30:21 -0400 (Reuters Health)

LONDON (Reuters) - European regulators have recommended approval of a new oral drug from Gilead Sciences to treat hepatitis C and an HIV medicine from GlaxoSmithKline, both of which are expected to be major sellers.

Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

The HCV tablet, Sovaldi (sofosbuvir), obviates the need for the injectable drug interferon. Two other new antiviral drugs, Incivek (telaprevir) from Vertex Pharmaceuticals and Victrelis (boceprevir) from Merck & Co, have cured more HCV patients in recent years, but both are protease inhibitors and are still used in combination with injections.

Sovaldi was recommended by an expert advisory committee of the U.S. Food and Drug Administration last month and a final decision from the FDA is expected by December 8.

GSK's HIV drug, Tivicay (dolutegravir), belongs to a novel class known as integrase inhibitors that block the HIV virus from entering cells, and is designed to be used in combination with other HIV drugs.

In addition, the European agency recommended approval of a new two-in-one diabetes drug called Xigduo (dapagliflozin/metformin) from Bristol-Myers Squibb and AstraZeneca.

The European Medicine Agency (EMA) said its committee of experts also gave the green light to a tuberculosis drug from Japan's Otsuka, following a review of an earlier rejection.

 
 
 
 
                 
 
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