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J&J gets FDA panel backing for canagliflozin

Moves ahead of BMS/AZ’s Forxiga in race for US approval as first in new class of diabetes drug

J&J headquarters

Johnson & Johnson took a step closer to bringing the first in a new class of diabetes drugs to the US market after an FDA advisory committee backed approval of canagliflozin yesterday.

The panel voted by 10 to 5 in favour of approving the sodium glucose cotransporter-2 (SGLT2) inhibitor, although a separate vote revealed there are still safety concerns with the drug, which were flagged up in FDA documents ahead of the meeting.

Committee members discussed the cardiovascular profile of canagliflozin at length during the meeting but eventually voted by the narrowest of margins - 8 to 7 - that J&J's drug had an acceptable cardiovascular risk profile.

Other possible safety consideration reviewed at the meeting included effects on bone mineral density and fractures and renal effects, with some panellists suggesting that labelling for the drug should indicate it should not be used in patients with impaired renal function.

In phase III trials canagliflozin was found to reduce the glomerular filtration rate (GFR) of the kidneys, although this did not appear to get worse over time.

The first SGLT-2 inhibitor to reach the market was Bristol-Myers Squibb and AstraZeneca's Forxiga (dapagliflozin), which debuted in the EU last year.

In the US however Forxiga has been delayed by an FDA request for additional information regarding a possible link to cancer and liver damage, so with a positive vote in the bag, J&J looks on track to bring its candidate to the US market first.

Another candidate in the class - Boehringer Ingelheim and Eli Lilly's empagliflozin - is also coming through development and should be submitted for approval later this year.

Analysts have suggested that the SGLT-2 inhibitors could become blockbuster medicines thanks to the increasing incidence of diabetes around the world and the fact that they control blood glucose independently of insulin and so can be used even in patients with dramatically reduced insulin function.

The drugs work by promoting excretion of glucose via the urine, and seem to be free of certain side effects - such as weight gain - that are seen with other oral anti-diabetic agent (OAD) classes. They also appear to reduce blood pressure.

11th January 2013

From: Sales



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