USFDA approves safer diabetes drug which acts on kidneys

A novel anti-diabetic drug that lowers blood glucose levels by acting on the kidneys, instead of the liver or the pancreas, has been approved by the USFDA.

The drug, Invokana (Canagliflozin), works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels in diabetics. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes.

However, FDA has asked for some more safety data from the drug company, Janssen Pharmaceuticals, including a cardiovascular outcomes trial, an enhanced pharmacovigilance programme to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions/photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes. It has also asked for a bone safety study.

While there are concerns about the cardiovascular and other side-effects of Canagliflozin, the uniqueness of its mechanism of action is expected to spawn a few more of its kind over the next few years.

While marvelling at the uniqueness of Canagliflozin, doctors in India are cautious in their prognosis for its future not just because of the side-effects but also because some of them feel the action through the kidneys is in itself a limiting factor in the efficacy of the drug.

It is only in combination with other drugs with different modes of action that it may achieve good results, they say. However, the possibility of combination drug therapy means that at least some diabetics who are on insulin can take a break from the daily needle pricks.

… contd.



Tags: novel anti-diabetic drug, drug lowers blood glucose, USFDA

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