FDA calls for more data for diabetes drug

Tue, 27 Feb 2007
The Food and Drug Administration have called for extra information regarding the Novartis drug Galvus, according to the Swiss pharmaceutical company . The data has to be supplied before the FDA can make any decision on approval.

Novartis said that the FDA is looking for a greater depth of information, in particular a clinical study amongst patients who have kidney impairment. The global head of development at Novartis Pharma AG, James Shannon, reportedly said: "We are confident in the safety and efficacy of Galvus and will continue working closely with the FDA to agree on what final actions are required to obtain U.S. approval."

Galvus is part of a new series of diabetes medicines known as DPP-4 inhibitors. If it gains approval, the drug could become a major earner for the company, netting them serious profits in the diabetes market. Galvus is also not yet approved in the European Union, with a decision pending.

An approval could benefit diabetics and healthcare services around the world.
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