WASHINGTON — A potential blockbuster diabetes medication from Bristol-Myers Squibb appears free from heart-related side effects that have plagued similar treatments, federal health officials said Monday.
Despite low rates of heart attacks and related problems in testing, the Food and Drug Administration will still ask an outside panel to scrutinize the company’s safety data at a meeting Wednesday.
Bristol-Myers and partner AstraZeneca have asked the FDA to approve Onglyza to reduce blood-sugar levels in patients with Type 2 diabetes. The drug uses a chemical reaction similar to Merck’s Januvia and would compete against the blockbuster medication, which had sales of $1.4 billion last year.
The drug is part of a new wave of medications taking aim at the U.S. diabetes market, which has grown to more than $5 billion as the disease becomes more prevalent.
Regulators have begun demanding more rigorous safety testing of diabetes drugs since a 2007 analysis suggested GlaxoSmithKline’s blockbuster pill Avandia could increase heart risks.
