EU Approves Dapagliflozin for Diabetes After U.S. Rejection

November 14, 2012

(Reuters) - European regulators have approved the first in a new class of diabetes medicines that work independently of insulin to control blood sugar, the drug's developers Bristol-Myers Squibb Co and AstraZeneca Plc said on Wednesday.

The approval of dapagliflozin (Forxiga) by the European Commission stands in stark contrast to the rejection of the drug in January by U.S. regulators, who cited concerns about the risk of cancer and liver injury and asked for more clinical data on the once-daily tablets.

The European Medicines Agency in April said it was satisfied those issues had been addressed in the drug's product label and via a risk management plan for the medicine. But many industry analysts believe the drug's dim prospects in the larger U.S. market will sharply curtail its potential sales.

Forxiga works by blocking a protein called SGLT2, or sodium-glucose cotransporter 2. It is meant to be used in combination with other treatments for type 2 diabetes, including insulin, or as a stand-alone treatment for patients who cannot tolerate the widely used oral treatment metformin.

Bristol-Myers and AstraZeneca said Forxiga in clinical trials was associated with a low risk of hypoglycemia. Use of the drug in clinical trials was also associated with weight loss and declines in systolic blood pressure.

Johnson & Johnson is awaiting approval of its own SGLT2 inhibitor, canagliflozin. Like Forxiga, it blocks reabsorption of glucose by the kidney and increases glucose excretion in the urine to lower blood sugar, and is also associated with drops in body weight and blood pressure.