Roche has stopped the development of its Aleglitazar diabetes drug after the independent Data and Safety Monitoring Board (DSMB) recommended it halt the drug’s phase III trial due to safety signals and lack of efficacy.
The Swiss pharmaceutical giant said based on this recommendation it has terminated the AleCardio trial and all other trials involving aleglitazar.
Roche global product development chief medical officer and head Hal Barron said: "We are disappointed by this outcome as we hoped that Aleglitazar would provide significant benefit for patients with type 2 diabetes who are at risk of cardiovascular disease."
However, he insisted the safety of the patients was the company’s first priority.
The drug has caused an increase in fractures, kidney problems and heart failure in the trial, reported The New York Times.
The AleCardio trial evaluated the efficacy and safety of Aleglitazar in patients with a recent acute coronary syndrome event and type 2 diabetes.
Unusually, Aleglitazar was designed to treat cardiovascular risk factors as well as diabetes, but not through the traditional route of lowering a patient’s blood sugar, which has not generally been shown to lower the risk of heart attacks and strokes.
Roche said the data from the trial would be further analysed to completely understand the findings, and will be made available at a future medical meeting.
The discontinuation of Aleglitazar could affect GlaxoSmithKline’s diabetes drug Avandia, which works in a similar way.
Avandia was banned in the Europe in 2010 and is severely restricted in the United States because of fears it may raise the risk of heart attacks and strokes. The Food and Drug Administration is currently deciding on whether to ease these restrictions.
