AstraZeneca, Bristol-Myers diabetes drug wins U.S. OK

AstraZeneca PLC and Bristol-Myers Squibb Co won U.S. approval on Friday to sell a new pill for adults with diabetes.

Onglyza enters a field clouded in recent years by concerns about heart-related risks. U.S. regulators have pressed manufacturers to more closely evaluate cardiovascular safety of proposed new medicines.

The Food and Drug Administration said Onglyza was not linked to increased heart problems in low-risk patients but the agency was requiring future study cardiovascular safety for higher-risk diabetics.

Though there are numerous diabetes therapies on the market, some cause weight gain or other complications and many patients do not reach optimal blood sugar levels, creating an opportunity for new treatments.

The companies hope Onglyza will carve out substantial sales by competing against Merck & Co's blockbuster drug, Januvia, which had $1.4 billion worldwide sales in 2008.

BMO Capital Markets analyst Robert Hazlett forecast Onglyza sales of $60 million in 2009, rising to $450 million in 2011 with peak sales approaching $1 billion over time.

Onglyza, a once-a-day pill known generically as saxagliptin, is AstraZeneca's first new drug since cholesterol fighter Crestor went on sale in 2003.

Both Onglyza and Januvia enhance the body's ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.

The drugs are cleared to treat Type 2 diabetes, which is linked with obesity, poor diet and lack of exercise. Nearly 24 million people in the United States, or nearly 8 percent of the population, have the condition, government statistics show.

FDA officials took a closer look at the cardiovascular safety of diabetes medicines after researchers linked GlaxoSmithKline PLC's pill Avandia to greater heart-related risks in 2007. A strong warning was added to the drug, although Glaxo says it is as safe as other approved diabetes medicines.

Onglyza's most common side effects include upper respiratory tract and urinary tract infections and headaches, the FDA said. Allergic-like reactions such as rashes and hives also were reported.
European regulators recommended approval of Onglyza in June, clearing the way for its launch there in the coming months.

Shares of Bristol-Myers gained 0.8 percent to close at $21.74 on the New York Stock Exchange. AstraZeneca shares gained 0.2 percent to close at $46.44, also on the NYSE.

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