J&J Gains FDA OK For First-In-Class Type 2 Diabetes Drug Invokana

J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.

Despite lingering skepticism about whether interim data from an ongoing cardiovascular trial would be enough to convince FDA to clear an NDA, Johnson & Johnson’s Janssen Pharmaceuticals Inc. unit gained approval for its type 2 diabetes treatment Invokana (canagliflozin) on March 29.

The drug has been tested in nine clinical trials in more than 10,000 patients, both as a standalone therapy, and...

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