Makers of new diabetes drug hope more data will help drug win FDA approval

diabetes illus250x03 Makers of new diabetes drug hope more data will help drug win FDA approvalBlood sugar levels were improved, body weight was reduced, and blood pressure was lowered in patients who were given a new type 2 diabetes drug, according to the drug’s makers, Bristol-Myers Squibb and AstraZeneca. The treatment, known as dapagliflozin, was pitted against a placebo in clinical trials in patients with type 2 diabetes who were also taking a combination of metformin plus sulfonylurea.

Dapagliflozin is a once daily pill that was approved in the European Union under the brand name Forxiga last November. It is also sold in Australia, Brazil, Mexico and New Zealand. Dapagliflozin works by removing excess blood sugar from the body.

The U.S. Food and Drug Administration (FDA) rejected the drug in January 2012 because of concerns that the medication may increase the risk for breast and bladder cancer. Bristol-Myers Squibb and AstraZeneca resubmitted the drug with several new studies and additional long-term data extending up to four years. The FDA agreed to reconsider the drug with a goal of voting whether to approve it by January 11, 2014.

Dapagliflozin is in a class of type 2 diabetes medications known as SGLT-2 inhibitors. Canagliflozin, known by the brand name Invokana, is the only other SGLT-2 currently marketed in the United States in this class. The drug empagliflozin was approved by the FDA and is expected to be marketed soon.

Type 2 diabetes drugs have come under closer scrutiny by the FDA in recent years after the blockbuster drug Avandia was linked to fatal heart attacks and its use severely restricted in 2010. A year later, the FDA warned that Actos had been associated with bladder cancer risk. Recent studies have also linked the drugs Januvia and Byetta with acute pancreatitis and pancreatic cancer.

Source: BBC