Experimental Diabetes Drug Makes Comeback
WASHINGTON (AP) -- A panel of federal health advisers has overwhelmingly backed the benefits of an experimental diabetes drug that uses a new method to reduce blood sugar, setting aside previous concerns about the pill's safety.
The Food and Drug Administration panel voted 13-1 on Thursday in favor of the drug from Bristol-Myers Squibb and AstraZeneca, downplaying possible links to bladder cancer and liver toxicity. Concerns over those risks led the same group of experts to vote against the drug in 2011, followed by a formal rejection by the FDA in early 2012.
The FDA is not required to follow the advice of its panels, though it often does.
Dapagliflozin is a once-a-day pill designed to help diabetes patients eliminate excess sugar via their urine. That differs from older drugs that decrease the amount of sugar absorbed from food and stored in the liver. The drug's developers have touted dapagliflozin as a new treatment option for the more than 25 million people in the U.S. with diabetes.
Panelists said newly submitted information from the companies provides reassurance that the drug is not connected with any life-threatening side effects.
Panelists said that 10 reports of bladder cancer reported among 6,000 patients taking the drug were likely due to a statistical fluke, and not caused by the drug. They noted that six of the 10 cancer cases developed in the first six months of the study. Since tumors are generally slow-growing they said it was unlikely dapagliflozin triggered the cancer.
"The risk appears to be low enough to go ahead, but there is surveillance needed to make sure we're not missing something," said panelist Peter Savage of the National Institutes of Health.
Bristol-Myers and AstraZeneca have agreed to monitor any reports of bladder cancer in an ongoing trial looking at stroke, heart attack and other cardiovascular issues.
Under recent FDA guidelines, drugmakers must provide more information about diabetes drugs' effects on the heart. The new policy followed several high-profile safety controversies over popular diabetes medications.
Dapagliflozin was approved in the European Union last November under the brand name Forxiga. If it is approved in the U.S., it would be the second drug from the so-called SGLT2 class to win U.S. approval. In March the FDA approved Johnson & Johnson's Invokana, which also works by eliminating excess sugar through patients' urine.
People with type 2 diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or have become resistant to the hormone, which controls blood sugar levels. Diabetics often require multiple drugs with different mechanisms of action to control their blood sugar levels.
New York-based Bristol-Myers Squibb Co. and London-based AstraZeneca PLC already co-market the diabetes drug Onglyza, which increases insulin production while reducing glucose production.