PRINCETON, N.J. (AP) — Drugmakers Bristol-Myers Squibb Co. and AstraZeneca PLC say their experimental diabetes pill has gotten its first major approval, in the European Union.
Forxiga (for-SEE'-gah), a once-a-day pill for adult Type 2 diabetes patients, is the first drug approved in a new class called SGLT2 inhibitors.
Known chemically as dapagliflozin (da-pah-GLEH'-flo-zihn), Forxiga works independently of insulin to remove excess blood sugar from the body differently than other Type 2 diabetes drugs.
It can be taken alone or with insulin or other medicines that lower blood sugar.
Last January, the U.S. Food and Drug Administration said it wouldn't approve the drug without more data. Bristol-Myers says the two drugmakers now plan to provide additional data from ongoing patient studies and reapply for approval in mid-2013.
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