FDA: Bristol-Myers diabetes drug appears safe
Pills
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.
Analyst estimates of Onglyza’s market potential vary, given its similarity to a more established drug. Sales estimates range from $300 million per year to more than $1 billion.
Shares of New York-based Bristol-Myers climbed 36 cents, or 1.7 percent, to close at $21.02 Monday. U.S.-traded shares of London-based AstraZeneca rose $1.87, or 5.8 percent, to $34.25.
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.
Under guidelines issued last year, FDA requires companies to test diabetes drugs on more high-risk patients, including the elderly, to detect potential heart problems. Detecting heart risks connected with diabetes drugs is challenging because patients with the disease are already at risk of heart problems.
Because Bristol-Myers and AstraZeneca conducted their studies before the guidelines were released, their testing “was not designed to prospectively measure cardiovascular risk,” agency reviewers noted. As a result the FDA said there is “insufficient information” to determine if some heart problems were related to the drug, according to briefing documents posted online.
November 21st, 2009 at 3:48 am
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