J&J's Invokana clears FDA

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The FDA has approved J&J's Invokana (canagliflozin) for type 2 diabetes, making it the first of a new class called sodium-glucose co-transporter 2 (SGLT2) inhibitors on the US market.

SGLT2 inhibitors block glucose reabsorption by the kidney, and could be paired with DPP-4 inhibitors and GLP-1 drugs down the road, presenting a possible threat to Merck's Januvia, as we noted in our Therapeutic Focus earlier in March.

The approval follows a 10-5 vote in favor of approval by an FDA advisory committee that weighed concerns about possible cardiovascular safety signals. It gives J&J a first-to-market edge while AstraZeneca and Bristol-Myers Squibb prep a second try for their SGLT2 inhibitor Forxiga (dapaglifozin), which received an FDA complete response letter in January, 2012. Forxiga won approval in the EU in November but was slighted by the UK's NICE in January. NICE said more data was needed on efficacy and declined to recommend the drug. In 2011, an FDA advisory committee voted 9-6 to recommend against approving the drug over concerns about breast and bladder cancers.

As Cegedim's Jerry Maynor writes in his MM&M Web Exclusive, the approval is sure to goose marketing spend, as the crowded diabetes market is a pricey one to launch in. Boehringer Ingelheim and Eli Lilly spent $30 million on marketing Tradjenta in its first quarter on the market, Maynor noted.

Around 24 million Americans suffer from type 2 diabetes, which makes up around nine out of ten cases of diabetes in the US.

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