AstraZeneca-Bristol drug just as effective as generic on market, trial results show
STOCKHOLM An investigational diabetes drug works as well as a generic already on the market, according to results of a late-stage clinical trial announced Friday by AstraZeneca and Bristol-Myers Squibb.
The two companies said phase-3 trial results showed that their investigational drug dapagliflozin combined with the widely available generic metformin was as effective as glipizide combined with metformin, compared with metformin alone. In addition, patients in the dapagliflozin group experienced weight loss, compared with weight gain in those taking glipizide, as well as a reduced number of patients experiencing abnormally low blood sugar, known as hypoglycemia.
Results from the study were presented at the 46th annual meeting of the European Association for the Study of Diabetes.
FDA to allow GSK’s Avandia, with restrictions
SILVER SPRING, Md. The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes drug made by GlaxoSmithKline.
The agency said Thursday that it would restrict access to the Type 2 diabetes medication Avandia (rosiglitazone) in response to clinical study data suggesting that its use can increase the risk of heart attacks and strokes.
The FDA is requiring GSK to develop a restricted access program for the drug under a risk evaluation and mitigation strategy. Under the REMS, Avandia will be available to patients only if they cannot control their glucose levels with Actos (pioglitazone), a drug made by Takeda in the same class as Avandia.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” FDA commissioner Margaret Hamburg said. “We are seeking to strike the right balance to support clinical care.”
Actos has some issues of its own. Last week, the FDA said it would conduct a safety review of the drug after receiving data from a study conducted by Takeda suggesting that some patients taking the drug for the longest periods of time and in the highest dosage could be at risk for bladder cancer. The study did not show an overall association between taking Actos and the risk of bladder cancer, and the FDA said it had not concluded that a risk existed.
Abbott, Reata ink deal for chronic kidney disease treatment
ABBOTT PARK, Ill. Drug makers Abbott and Reata Pharmaceuticals have signed an agreement concerning a drug for chronic kidney disease.
The two companies said Thursday that they would develop and commercialize bardoxolone methyl, currently in mid-stage clinical trials.
Under the agreement, Abbott will have exclusive rights to develop and commercialize the drug outside the United States, except for some Asian markets, and obtain a minority equity investment in Reata, which will receive $450 million. Reata also will receive additional milestone payments and royalties on future sales.