Diabetes Drug Appears Safe, For Now
Federal health officials are examining a potentially ground breaking diabetes medication from Bristol-Myers Squibb because it appears free of heart-related side effects that have plagued similar treatments.
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 want the FDA to approve Onglyza, which promises to decrease blood sugar levels in patients with type 2 diabetes.
Type 2 diabetes affects some 23 million adults and teenagers in the United States.
The drug would compete with Merck’s, which had sales of $1.4 billion last year.
Early estimates of Onglyza’s market potential differ, but sales estimates range from $300 million per year to more than $1 billion.
Shares of New York-based Bristol-Myers climbed 29 cents to $20.95 in afternoon trading. U.S.-traded shares of London-based AstraZeneca rose $1.56 cents, or 4.8 percent, to $33.94.
Regulators are demanding more rigorous safety testing of diabetes drugs, after a study in 2007 suggested GlaxoSmithKline’s blockbuster pill Avandia could increase heart risks.
The FDA now requires companies to test diabetes drugs on more high-risk patients, including the elderly, to detect potential heart problems. However, that process is difficult because patients with the disease are already at risk of heart problems.
Bristol-Myers and AstraZeneca conducted their studies before the guidelines were released.
Therefore, 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.
The FDA asked the companies to analyze reports of heart problems with the drug. Based on that assessment, the level of heart attacks, deaths and other cardiovascular problems appeared well within the new safety limits imposed by the FDA.
A decision on whether to approve the drug is expected by the end of April.
People with Type 2 diabetes have problems breaking down carbohydrates, because their bodies have become resistant to the protein insulin, which is critical to digesting sugars.
Diabetics are at higher risk for heart attacks, kidney problems, blindness and other serious complications.
Onglyza, known generically as saxagliptin, belongs to the DPP-4 inhibitor family of the diabetes medications; the drug works by blocking the DPP-4 enzyme, which spurs release of insulin-boosting proteins that help control blood sugar levels.
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