Type 2 diabetes drug Empagliflozin launched in US

Wed, 27 Aug 2014
A new medication for treating type 2 diabetes called empagliflozin is now available at pharmacies across the USA following recent approval from the country's health regulatory body.

The drug's manufacturers, Boehringer Ingelheim and Eli Lilly, announced in a statement that empagliflozin tablets are now available, under the brand name Jardiance, by prescription to adults with type 2 diabetes to help improve blood glucose control, in addition to diet and exercise.

Approved by the U.S. Food and Drug Administration (FDA) at the start of August, empagliflozin is a once-daily sodium glucose co-transporter (SGLT2) inhibitor. Like other drugs in this class, it works in a unique way to lower blood sugar levels by blocking the reabsorption of glucose in the kidneys and promoting excretion of excess glucose in the urine.

FDA approval of the drug was based on data from more than 10 multinational clinical trials involving over 13,000 adults with type 2 diabetes. The late-stage studies showed empagliflozin significantly lowered HbA1c after 24 weeks as a stand-alone treatment or in combination with metformin, sulfonylureas, insulin and pioglitazone (Actos).

The results also showed modest reductions in both body weight and systolic blood pressure, keeping in line with other SGLT2 inhibitors which have also been shown to be effective for weight loss.

Urinary tract infections and vaginal yeast infections were the most commonly reported adverse side effects among empagliflozin users, according to the statement, while hypoglycemia was a common reaction in patients also treated with a sulfonylurea or insulin.

Empagliflozin was recommended for approval by the European Medicines Agency in April 2014 and launched in the UK on August 14.
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