January 9, 2013
Johnson & Johnson's (NYSE: JNJ ) diabetes drug canagliflozin produced solid phase 3 data, but the FDA is concerned about the safety of the drug. It will be reviewed by a Food and Drug Administration advisory committee tomorrow.
In the briefing document [opens in PDF] for the committee, FDA reviewers noted a larger number of cardiovascular events during the first 30 days patients took canagliflozin compared to the number of events for those taking placebo. The agency also highlighted an increase in bone fractures in patients taking canagliflozin and potential risks for patients with moderate renal impairment.
Canagliflozin is an inhibitor of sodium glucose cotransporter-2, or SGLT-2, the same class of drugs as Bristol-Myers Squibb (NYSE: BMY ) and AstraZeneca's (NYSE: AZN) dapagliflozin, which was rejected by the FDA last year. As with canagliflozin, the FDA questioned the risk-benefit profile of the drug, although in dapagliflozin's case it had to do with a potential cancer risk.
The FDA should decide the fate of canagliflozin in the next few months. The agency often follows the panel's recommendation, but isn't required to do so.