Positive opinions from CHMP for Forxiga, Jakavi, Rienso and Flutiform but not Glybera

22 April 2012

There was a batch of good news for several drugmakers coming out of the discussion meetings last week of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), but also delivered a negative for Amsterdam Molecular.

First up, the CHMP has recommended AstraZeneca (LSE: AZN) and Bristol-Myers Squibb’s (NYSE: BMY Forxiga (dapagliflozin) tablets for the treatment of type 2 diabetes, as an adjunct to diet and exercise, in combination with other glucose-lowering medicinal products including insulin, and as a monotherapy in metformin intolerant patients.

Dapagliflozin is an investigational selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2), which works independently of insulin. This is the first in the new SGLT2 class to receive a positive CHMP opinion for the treatment of type 2 diabetes, a disease where high unmet medical need exists.

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