Dapagliflozin approved in Europe

On 14 November 2012, Bristol Myers Squibb (BMS) and AstraZeneca (AZ) announced that dapagliflozin (Forxiga) has been approved by EMA for the treatment of type 2 diabetes.  The European agency issued a positive opinion for the drug in April.

Dapagliflozin is the first inhibitor of sodium-glucose cotransporter 2 (SGLT2), which prevents reabsorption of glucose by the kidneys – and thus increases glucose excretion in the urine.  While there have been concerns that this mechanism of action may increase the rate of urinary tract infections (UTIs), this hasn’t proved to be a major issue inclinical trials.  And the increased excretion of glucose leads to weight loss and a reduction in blood pressure, which are likely to make this oral product attractive to overweight diabetes patients. 

The next challenge for the two companies will be securing reimbursement for Forxiga, and then driving uptake in the market.

Link to the AstraZeneca Press Release

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