EU Committee Backs Bristol, Astra Diabetes Drug Forxiga

Law360, New York (April 20, 2012, 4:48 PM EDT) -- AstraZeneca PLC and Bristol-Myers Squibb Co. should receive approval for diabetes drug Forxiga, European regulators said Friday, delivering a pleasant surprise for firms that were rebuffed by the U.S. Food and Drug Administration earlier this year.

The move by a committee of the European Medicines Agency marks a reversal of fortune after the FDA in January asked for extra clinical data before endorsing the Type 2 diabetes treatment, whose active ingredient is dapagliflozin.

In giving its blessing, the EMA committee noted that risks of bladder and...
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