- The Washington Times - Wednesday, April 1, 2009

SILVER SPRING, MD. (AP) - A federal panel said Wednesday a diabetes drug from Bristol-Myers Squibb appears free from heart problems seen with similar drugs but added that long-term studies should be done after approval to confirm its safety.

Bristol-Myers and partner AstraZeneca have asked the Food and Drug Administration to approve their drug Onglyza for millions of Americans with type 2 diabetes.

The drug is the first to go before the FDA’s panel of diabetes experts since the agency issued new safety guidelines for diabetes treatments last year. Concerns about heightened risks of heart attack with GlaxoSmithKline’s blockbuster pill Avandia created a storm around the FDA and the British drugmaker in 2007.

The panel of outside experts voted 10 to 2 that the companies’ data do not suggest deadly side effects like heart attack, stroke and other problems. But panelists voted unanimously that the companies should be required to continue studying the drug in high-risk patients, to assure the drug’s heart-safety.

“Our primary goal is to protect the patient, and I just don’t think there’s enough data in the studies to be absolutely certain that there is no risk,” said panel chairman Dr. Kenneth Burman of Washington Hospital Center.

The FDA is not required to follow the group’s recommendation, though it normally does. A final decision is expected by April 30.

The two votes provide a mixed picture of the government’s regulatory stance on dozens of diabetes drugs headed for the $5 billion U.S. diabetes drug market.

While FDA’s advisers appear willing to accept safety findings based on a relatively narrow group of patients, they want to see those data confirmed in large, long-term studies. Such studies are expensive and require years to complete.

Bristol-Myers and partner AstraZeneca conducted their studies of Onglyza before the FDA issued its guidelines on heart safety in December. As a result, they primarily tested the drug on otherwise healthy diabetes patients _ instead of those with elevated heart risks, as the FDA now recommends.

“I think the data presented give us good insight into the cardiovascular risk for this population,” said panelist Dr. John Teerlink of the San Francisco Veterans Affairs Medical Center. “I just have no idea what happens when you give this to someone who does have chronic heart disease.”

The drugmakers conducted a retrospective analysis that showed very low rates of heart attack, stroke and related problems, but it wasn’t enough to rule out the need for follow-up.

“All of us are uncomfortable with the data, but given the circumstances this was the best way it could be done,” said panel chairman Kenneth Burman of Washington Hospital Center.

The drugmakers said in a joint statement they will “continue to work closely with the FDA to support the review of Onglyza.”

On Thursday the same panel will review a drug from Novo Nordisk, one of many companies looking to capitalize on the U.S. epidemic of type 2 diabetes, which affects about 23 million adults and teenagers.

People with the disease have trouble breaking down carbohydrates, because their bodies have become resistant to the protein insulin. They are at higher risk for heart attacks, kidney problems, blindness and other serious complications.

Bristol-Myers and London-based AstraZeneca hope their drug can take sales away from Merck’s blockbuster product Januvia, a similar drug that had sales of $1.4 billion last year.

But analysts have mixed opinions about Onglyza’s market potential, with estimates ranging from $300 million annually to over $1 billion.

Credit Suisse’s Catherine Arnold told investors the drug “does not appear differentiated” from Merck’s drug, which she said will help Januvia keep market share.

Shares of New York-based Bristol-Myers rose 36 cents Wednesday to close at $21.97. Shares of London-based AstraZeneca rose 45 cents to close at $35.90.



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