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FDA to Review New Diabetes Drug

Wed, 04/01/2009 - 4:30am
WASHINGTON (AP) — The drug industry and investors will be carefully monitoring a government meeting Wednesday as Bristol-Myers Squibb presents a new diabetes drug to experts who have become increasingly cautious of safety risks. Bristol-Myers is the first drug company to go before the Food and Drug Administration's panel of diabetes experts since the agency issued new guidelines for testing heart risks connected with diabetes treatments. The more cautious approach follows a 2007 uproar over figures suggesting GlaxoSmithKline's blockbuster pill Avandia increased heart attack risks. Bristol-Myers and partner AstraZeneca conducted studies of their drug Onglyza before the FDA issued its new guidelines. But an analysis of heart problems conducted after the fact showed low levels of heart attack, stroke and related problems, according to FDA documents released Monday. "We expected that the FDA would be more critical of the overall safety profile, but our take on the documents is that the agency seems relatively supportive," Credit Suisse analyst Catherine Arnold said in a note to investors. FDA will ask its panel of experts to vote on whether the companies showed that their drug is safe. They will also vote on whether the companies should have to conduct follow-up safety studies, which would drive up expenses for the drugmakers. While the agency is not required to follow the panel's advice, its recommendations will have far-reaching implications for dozens of drugmakers working on experimental treatments for diabetes. The market for diabetes drugs has swelled to more than $5 billion, according to IMS Health, as the disease becomes more prevalent. Some 23 million adults and teenagers in the U.S. have type 2 diabetes, which interferes with the breakdown of carbohydrates, driving blood sugar to dangerously high levels. Onglyza belongs to the DPP-4 inhibitor family of the diabetes medications, which also includes Merck's drug Januvia. The drugs work by blocking the DPP-4 enzyme, which spurs release of insulin-boosting proteins that help control blood sugar levels. Bristol-Myers and London-based AstraZeneca hope their drug can take sales away from Merck's blockbuster product, which had sales of $1.4 billion last year. But analysts have mixed opinions about Onglyza's market potential because of its similarities to Januvia. Estimates range from $300 million annually to over $1 billion. Credit Suisse's Arnold told investors the drug "does not appear differentiated" from Merck's drug, which she said will help Januvia keep market share. The FDA is scheduled to make a decision on the drug before the end of April.
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