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Bristol-AstraZeneca Diabetes Drug Wins U.S. FDA Approval

A diabetes pill from Bristol-Myers Squibb Co. and AstraZeneca Plc won U.S. approval, becoming the second in a new class of medicines to treat the disease.

The Food and Drug Administration cleared the drug, known as dapagliflozin, according to a statement from the agency today. The FDA had rejected the Type 2 diabetes treatment, to be called Farxiga, in 2012 after advisers raised concern about the bladder and breast cancer risk. Additional data downplayed the potential harm and advisers backed the pill in December.

Johnson & Johnson gained clearance in March to sell Invokana, the first in a class of therapies called SGLT2 inhibitors that includes dapagliflozin. The New York-based Bristol-Myers and London-based AstraZeneca drug, approved in Europe in 2012, may generate $160 million in sales this year for AstraZeneca, rising to $1.5 billion in 2020, Seamus Fernandez, an analyst with Leerink Partners has estimated.

Bristol-Myers is selling its share of the diabetes alliance it has with AstraZeneca for as much as $4.3 billion. The partnership includes dapagliflozin, Onglyza, Byetta and Bydureon, Bristol-Myers said in a Dec. 19 statement.

Diabetes is the seventh-leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. The disease, defined by high levels of sugar in the blood, affected almost 26 million people in the U.S. in 2010, or about 8.3 percent of the population, the CDC said.

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