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FDA approves new diabetes pill
Takeda's combination medication approved by FDA is the company's second approval this summer.
August 30, 2005: 10:11 AM EDT
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - On Monday the Food and Drug Administration approved a combination pill for diabetes from Takeda Pharmaceuticals North America, a subsidiary of the Japanese drug manufacturer.

Actoplus Met, a single-pill combination of the diabetes drugs Actos and metformin, is designed to control blood sugar level in type 2 diabetics, Takeda (down $0.88 to $52.29, Research) said. Type 2 is the most common form of diabetes, affecting more than 90 percent of the 18.2 million diabetics in America.

Actos, which produced sales of nearly $2 billion for Takeda and its partner Eli Lilly & Co. (down $0.12 to $53.92, Research) in 2004, works by treating insulin resistance in diabetics who can't naturally produce their own insulin, while metformin reduces sugar levels in the liver.

Takeda said Actoplus Met should be available in October in two different dosages, to be taken once a day.

In a non-insulin diabetes drug market of about $4 billion, Actoplus Met will compete against Avandia, a $1.6 billion diabetes drug from GlaxoSmithKline (up $0.23 to $47.84, Research), according to Bernstein. Actoplus Met could also face competition from Muraglitazar, a drug candidate from Bristol-Myers Squibb (down $0.07 to $24.08, Research) and Merck & Co. (down $0.04 to $28.08, Research) that goes before an FDA advisory panel on Sept. 9. Like Actoplus Met, both of these drugs are orally administered pills.

It's the second FDA approval this year for Takeda. Rozerem, a sleeping medication, was approved July 22.

Takeda Pharmaceuticals North America is based in Lincolnshire, Ill.

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