ZURICH, Sept 28 (Reuters) - Novartis AG's NOVN.VX potential blockbuster diabetes treatment Galvus has been approved for use in the European Union, the Swiss drugmaker said on Friday.
The approval by the European Commission had been expected after a July recommendation by a committee of experts at the European Medicines Agency. It will boost prospects for a drug that faces a lengthy delay in getting to market in the United States.
Novartis has said it would not be ready to resubmit Galvus to U.S. regulators until mid-2009, following a request for more safety data.
The once-daily oral treatment was approved for use in combination with other common oral anti-diabetes medicines, metformin, sulfonylureas or thiazolidinediones, Novartis said in a statement. The approval applies to all 27 EU countries as well as Norway and Iceland.
Galvus works in a similar way to Merck & Co. Inc.'s MRK.N recently launched Januvia but its path to market has been delayed by worries over skin toxicity.
Merck’s big lead means Novartis may be at a disadvantage when its drug is finally approved in the United States, the world’s biggest drugs market, some analysts say.
Both Galvus and Januvia are so-called DPP-4 inhibitors, which are designed to enhance the body’s own ability to lower elevated blood sugar and could become an important new way to control type 2 diabetes, the most common form of the disease.
The manufacturers and many analysts believe DPP-4 drugs could become blockbusters because they are not associated with weight gain, a major side effect of some established diabetes drugs.
((Reporting by Sam Cage,
Editing by Anthony Barker
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