NEW YORK — Roche, the Swiss pharmaceutical giant, has discontinued development of a potentially important diabetes drug, a move that could raise new safety questions about the entire category of drugs, which includes the controversial diabetes medicine Avandia.
Roche said Wednesday that a safety monitoring committee had recommended halting a late-stage clinical trial of the drug, aleglitazar, because of “safety signals and lack of efficacy.” The company said that it decided to halt that study and all others involving the drug.
A spokesman for the company, which is based in Basel, Switzerland, said the drug had caused an increase in fractures, kidney problems, and heart failure in the trial.
Aleglitazar was designed to treat not only diabetes but cardiovascular risk factors like cholesterol as well. In a bold move, Roche was testing the drug not for its ability to lower blood sugar, the usual yardstick for a diabetes drug, but rather to see if it could prevent heart attacks and strokes in people with Type 2 diabetes.
A success would have been considered a major advance for diabetes.
Still, it was, perhaps, a long shot. Many other companies developing similar drugs abandoned their efforts years ago after running into various safety problems.
The failure of aleglitazar could conceivably play into the US Food and Drug Administration’s deliberations over GlaxoSmithKline’s diabetes drug Avandia, which has a somewhat similar mechanism of action.
New York Times