Gilead and GSK drugs for HCV and HIV win EU green light (updated)
22/11/2013 16:36
(Adds more on new drugs, detail on other decisions) LONDON, Nov 22 (Reuters) - European regulators have recommended approval of a new drug for hepatitis C treatment from Gilead Sciences GILD.O and an HIV medicine from GlaxoSmithKline GSK.L , both of which are expected to be major sellers. The European Medicine Agency (EMA) said on Friday its committee of experts also gave a green light to an Otsuka 4768.T tuberculosis drug, following a review of an earlier rejection. Analysts expect U.S.-based Gilead's sales to surge higher next year on the back of its new so-called HCV treatment known as Sovaldi, or sofosbuvir, for people infected with the liver-destroying hepatitis C virus. Clinical trials of sofosbuvir in combination with other experimental oral Gilead drugs resulted in more than 95 percent of patients being cured. GSK's Tivicay, or dolutegravir, is also forecast to be a significant new product for the British drugmaker. It will be sold through the ViiV Healthcare business, in which GSK is the biggest shareholder, alongside Pfizer PFE.N and Shionogi 4507.T . In addition, the European agency recommended approval of a new a new two-in-one diabetes drug called Xigduo from Bristol-Myers Squibb BMY.N and AstraZeneca AZN.L . 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. (Reporting by Ben Hirschler; Editing by Kate Kelland) ((ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net)) Keywords: EUROPE MEDICINES/