FDA notes heart events, tumors with Novo drug

March 31, 2009

(AP) -- Federal health officials say a potential blockbuster diabetes drug from Novo Nordisk appears to work. But they say questions remain about its effect on the heart and other organs.

Results from the Danish drugmaker show the liraglutide helped control blood sugar when used alone or in combination with other medications. But regulators have concerns about a small number of heart problems seen in patients as well as tumors when the drug was tested on rats and mice.

Novo Nordisk is hoping its once-a-day injection can take sales away from Byetta, a twice-a-day injection from Eli Lilly and Amylin Pharmaceuticals that has a similar formulation.

The FDA meets with its outside experts this week to review liraglutide and another drug looking to compete in the $5.1 billion U.S. market for diabetes drugs, which has grown rapidly as the disease becomes more prevalent.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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