FDA backs Avandia combo therapy
The US Food and Drug Administration has issued an approvable letter forGlaxoSmithKline's oral diabetes agent Avandia (rosiglitazone) in combination with insulin for the treatment of type 2 diabetes. The drug is currently indicated as a monotherapy and in combination with a sulfonylurea or metformin for patients with type 2 diabetes.
GSK says it plans to work closely with the FDA to deal with points raised in the approvable letter, and David Stout, the group's president of pharmaceuticals in North America, has said that "we remain committed to addressing the epidemic of type 2 diabetes in the USA by providing patients with a range of treatment options." Around 15 million people in the USA have type 2 diabetes, the most common form of the condition.
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