UK’s largest drug maker GlaxoSmithKline PLC yesterday breathed a sigh of relief when the FDA panel allowed their flagship diabetes drug Avandia to stay in the market but with strict warnings on the label.Glaxo’s diabetes drug was cracked down by the FDA after it wiped out heart failure as a negative side effect discovered in the trials conducted by the company.
Yesterday, the FDA panel voted 21-12 to keep the drug in the market but with strict warnings. The company’s clearance in U.S. market will fetch the same results worldwide. Timothy Anderson, an analyst at Sanford Bernstein & Co. in New York said, “While the product seems destined to remain on the market as an option for prescribers and their patients, Avandia is not fully out of the woods yet”. He also said that it is possible that Avandia could still face withdrawal in certain ex-U.S. markets, but the odds seem better now with the U.S. recommendation to stay on the market in hand.
Ellen Strahlman, Glaxo’s chief medical officer in her statement after the vote clarified Glaxo’s position and said, “Following today’s recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease,” she said. “Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine.”
Since 2007, Glaxo’s diabetes drug is facing staunch competition and is also losing its market share after a study revealed its adverse effects including bone loss, eye damage and stroke. “I find there to be very little clarity in the two days of analysis that we’ve been subjected to,” said Rebecca Killion, the panel’s patient representative. “This drug is not for everybody, but that may not mean that it’s not for anybody,” she added
