Forxiga diabetes drug wins EU approval

A new drug treatment for patients with type 2 diabetes has been given the green light by European regulators.
Forxiga – the first in a new class of diabetes drugs – received European Commission approval this week for use in combination with other treatments for type 2 diabetes, including insulin, or as a standalone treatment for patients who cannot tolerate metformin.
Produced by Bristol-Myers Squibb and AstraZenecan, the new once-daily tablet medication improves blood glucose control independently of insulin by blocking a protein called SGLT2, or sodium-glucose cotransporter 2.
The drugmakers said Forxiga was associated with a low risk of hypoglycemia (dangerously low blood sugar levels) in clinical trials, as well as reductions in both systolic blood pressure and body weight .
The safety of Forxiga was disputed earlier this year following its rejection by US regulators, who voiced concerns about the risk of cancer and liver disease and asked for more clinical trial data.
But in April, the European Medicines Agency (EMA) said it was satisfied those issues had been addressed in the drug’s product label and through a risk management plan for the medication .
Bristol-Myers said the company plans to resubmit its US marketing application for Forxiga and gain FDA approval by mid-2013.