Pharmaceutical

FDA to review drugs in new class of type 2 diabetes medications

diabetes illus250x03 FDA to review drugs in new class of type 2 diabetes medicationsTwo type 2 diabetes drugs in a new class of blood sugar lowering medications known as SGLT2 inhibitors are hoping to win approval from the Food and Drug Administration (FDA) – Johnson & Johnson’s canagliflozin, and empagliflozin, made jointly by Eli Lilly and Boehringer Ingelheim. The drug makers presented the benefits of their medications recently at the European Association for the Study of Diabetes meeting in Berlin.

The two drugs are among several of their kind for the treatment of diabetes, and are in various stages of development. The FDA is currently reviewing data for canagliflozin, and it is expected an application for empagliflozin will be submitted in 2013.

The new class of type 2 drugs, SGLT2 inhibitors, works by reducing blood sugar by causing it to be excreted in the urine. The first drug in this class to go under review was dapagliflozin, made by Bristol-Myers Squibb Co. and AstraZeneca. The FDA rejected it based on data that showed elevated rates of bladder and breast cancer. The agency also raised concerns about infections and possible liver damage.

The safety and efficacy of diabetes drugs was brought to the forefront two years ago when the FDA placed severe restrictions of the type 2 medication Avandia after it was associated with fatal heart attacks. A year later, the agency issued a warning that the type 2 diabetes drug Actos had been linked to a greater risk for bladder cancer. Both Avandia and Actos are in a class of medications known as TZDs.

There is much hope that SGLT2 inhibitors may be a safer class for diabetics, but the data will have to prove it in order for the FDA to grant clearance for the new class of drugs.

Canagliflozin is showing good results in clinical trials but some patients on a higher dose of the drug had to drop out due to adverse events such as higher increases in cholesterol levels, hypoglycemia, urinary tract infections and increased urination.

Empagliflozin is still in clinical trials with pivotal studies expected to wrap up later this year.

Source: Fierce Biotech