F.D.A. Delays Approval of New Diabetes Drug


F.D.A. Delays Approval of New Diabetes Drug

By ANDREW POLLACK

The Food and Drug Administration has decided not to approve the first of a new class of diabetes drugs, saying that more information was needed to assess the medicine’s safety and effectiveness.

The agency’s decision was announced Thursday morning by the developers of the drug, AstraZeneca and Bristol-Myers Squibb.

The companies said the F.D.A. wanted more data from continuing trials and might also require new clinical trials.

The decision is not a surprise, given that an advisory committee to the F.D.A. voted 9 to 6 in July against recommending approval. The committee cited a possible increased risk of bladder and breast cancers and of liver injury.

The drug, called dapagliflozin, has generated some interest among diabetes specialists because it has a novel mechanism of action that does not depend on influencing the production or use of insulin. Rather, it reduces blood sugar by causing more of the sugar to be excreted in the urine.

Numerous other companies have also been developing drugs of this type, which are called SGLT2 inhibitors.The drugs are aimed initially at Type 2 diabetes.

AstraZeneca and Bristol-Myers said they remained committed to developing dapagliflozin. While the companies did not estimate how long it could take to win approval, it could be years if new trials were required. European regulators have yet to decide whether to approve the drug.

In December, AstraZeneca suffered setbacks in the development of a drug for cancer and one for depression, while Bristol-Myers reported the failure of a liver cancer drug in a clinical trial. But Bristol-Myers has been showing some progress in drugs for treating hepatitis C.

The F.D.A. has become more cautious about diabetes drugs in part because of studies linking Avandia, a widely used diabetes drug from GlaxoSmithKline, to a possible increased risk of heart attacks.

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