FDA panel backs J&J diabetes drug Invokana (canagliflozin)

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted 10 to five to recommend approval health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development’s canagliflozin, proposed trade name Invokana, to treat type 2 diabetes in adult patients based on the efficacy and safety results from its comprehensive clinical development program. If it gains final approval from the FDA, Invokana would be the first in a new class medicines known as SGLT2 inhibitors.

However, as flagged up in briefing papers ahead of the advisory panel meeting, committee members raised concerns about low levels of heart attack, stroke and urinary tract infections seen in the first year of testing. The experts said those infections could be especially harmful to patients with kidney damage, a common side effect of diabetes. Moreover, most panelists recommended that the company be required to track those problems over the long term to tell whether they get worse.

Canagliflozin is an investigational, oral, once-daily medication for the treatment of adult patients with type 2 diabetes. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to people who do not have diabetes, which may contribute to elevated glucose levels, Janssen explained. Canagliflozin, a selective sodium glucose co-transporter 2 (SGLT2) inhibitor, blocks the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels diabetics who have elevated blood glucose levels.