Johnson & Johnson emerged from a showdown with FDA advisers with some scratches but ultimately a win on Thursday. An agency advisory committee backed approval of the company's experimental diabetes drug canagliflozin in a 10-5 vote after reviewers highlighted concerns about increased heart risks in patients on the treatment.
Most major drugmakers want or own a piece at the humongous diabetes market, and canaglifolzin offers J&J ($JNJ) a golden ticket into this lucrative arena. If the FDA approves the drug as the company hopes by the end of March, canagliflozin would be the first sanctioned SGLT2 inhibitor on the U.S. market, providing a fresh mechanism of blocking glucose reabsorption in the kidneys and boosting its exit in patients' urine.
Yet J&J faces questions about cardiovascular risks to patients on the drug. The FDA panel voted 8-7 that canagliflozin worried them about heart safety, Bloomberg reported. Agency reviewers noted that there were more cases of cardiovascular events in patients on the SGLT2 drug than in those taking a placebo in the first 30 days of a study, and LDL or bad cholesterol increases were associated with the drug.
The drug could proffer a new way to lower blood sugar and doctors have been seeking new solutions to the rising diabetes epidemic that affects more than 25 million Americans. Yet the FDA has already put the brakes on an SGLT2 drug from Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) over safety concerns.
And the support from the panel of non-agency experts doesn't guarantee that the regulator will stamp an approval on canagliflozin. If shot down, J&J could get beat the market by the AZ/BMS contender dapagliflozin or empagliflozin from diabetes partners Eli Lilly ($LLY) and Boehringer Ingelheim.
- here's the release
- read Bloomberg's article
- get more from the WSJ (sub. req.)
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