FDA Approves Avandia For Use in Combination with Sulfonylureas


By: dhtest

On April 3, SmithKline Beecham announced that the FDA has approved Avandia for use as a treatment in combination with sulfonylureas. Previously, Avandia had been approved for treating type 2 diabetes as both monotherapy and in combination with Glucophage.

In patients inadequately controlled on sulfonylureas alone, the safety and efficacy of Avandia was evaluated in combination with sulfonylureas. In three randomized, double-blind, 6-month studies, both fasting plasma glucose (FPG) and HbA1c were significantly improved in patients given Avandia plus sulfonylureas, as compared to those given sulfonylureas alone. The combination therapy produced and maintained impressive reductions in FPG and HbA1c throughout the duration of the trials.

Now Available in Canada

In another story, on March 30, Health Canada approved Avandia for the treatment of type 2 diabetes, making it the first drug available in Canada to directly treat insulin resistance.

“The Canadian Diabetes Association recommends that Canadians with diabetes discuss any new treatment option with their physician to determine if it is appropriate,” said Donna Lillie, director of research and professional education for the Canadian Diabetes Association.

It is estimated that 1.5 million Canadians are currently diagnosed with diabetes, while another 750,000 people are currently undiagnosed. In addition to Canada’s approval, Avandia has received marketing approval in 26 countries.



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