Het nieuwe middel dapagliflozin, een SGLT-2 remmer, lijkt vooralsnog niet geregistreerd te gaan worden voor de behandeling van type 2 diabetes. In verband met zorgen over de mogelijke verhoogde risico's van maligniteiten, lever- en nierproblemen heeft een adviescommissie van de FDA (Food and Drug Administration) een negatief advies uitgebracht aan de FDA. Aangezien de FDA meestal het advies van de commissie overneemt, is het onwaarschijnlijk dat dit middel op de korte termijn goedgekeurd gaat worden.


Bron: www.reuters.com


Panel votes 9-6 against dapagliflozin in Type 2 diabetes

* FDA panel says further safety, efficacy studies needed

* FDA to make final decision on drug by Oct. 28


SILVER SPRING, Md., July 19 (Reuters) - U.S. advisers rejected a new type of diabetes pill from AstraZeneca (AZN.L) and Bristol-Myers Squibb (BMY.N) over concerns about liver and cancer risks.

A Food and Drug Administration advisory panel voted 9-6 on Tuesday against recommending approval of the drug, called dapagliflozin, for adults with Type 2 diabetes.

Panel members said the clinical data did not provide enough certainty about the drug's cancer, liver and kidney risks, as well as its efficacy -- especially for the elderly.

The FDA usually follows the recommendations of its advisory panels and is due to make a final decision on the drug by Oct. 28.

An estimated 200 million people across the world, and close to 26 million in the United States, have diabetes. Most have Type 2 diabetes, the kind linked to poor diet and lack of exercise. (Reporting by Anna Yukhananov; Editing by Gary Hill)