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UPDATE 2-US advisers urge higher bar for new diabetes drugs

Thu Jul 3, 2008 4:17am IST
 
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(Adds impact, panel member quote, paragraphs 2-3; also adds analyst comments, detail, background)

By Lisa Richwine

SILVER SPRING, Md., July 2 (Reuters) - U.S. regulators should require drugmakers to study the potential heart risks of all new diabetes medicines, an advisory panel said on Wednesday.

The recommendation could force companies to run longer and more expensive studies and delay new entrants in a $6 billion U.S. market that was hit last year by concerns surrounding GlaxoSmithKline PLC's (GSK.L: Quote, Profile, Research) diabetes pill Avandia.

"Although it might be a little more burdensome ... we need more studies," said Dr. Clifford Rosen, a panel member and endocrinologist at the Maine Center for Osteoporosis.

Now, companies generally need to show only that their medicines lower blood sugar levels. That approach is inadequate for patients, panel members said.

The group of outside experts that advises the Food and Drug Administration voted 14-2 to recommend companies do a long-term study of cardiovascular effects or provide equivalent evidence to rule out an "unacceptable" risk of heart problems.

Studies need to last as long as five years to detect heart attacks, strokes and other problems, several panel members said. Many endorsed the idea of starting the study before approval and completing it after a drug reaches the market.

The requirement should apply to all experimental drugs even if they show no signs of concern in early testing, the committee said.  Continued...

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