FDA Panel Backs New Type of Diabetes Drug
Jan. 16, 2013 -- An FDA advisory panel has given its blessing to canagliflozin (Invokana) for the treatment of type 2 diabetes.
The panel voted 10 to 5 in favor of the drug’s approval, but did express concern about heart and stroke risks. The FDA is not obligated to follow the advice of its panels, but it usually does. The FDA is expected to give its decision in March.
Taken by mouth once a day, the drug could be the first in a new class of diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. Canagliflozin works to reduce the amount of blood sugar (glucose) reabsorbed by the kidneys. This results in glucose being expelled in the urine.
Preliminary data suggest that people who take the new medication have lower glucose levels and also lose weight. Studies of the new drug are ongoing.
The drug is being developed by Johnson & Johnson subsidiary Janssen Research & Development.
Safety Concerns Linger
Despite recommending approval of the new drug, panel members expressed concerns about risks of heart disease and stroke. But data on studies evaluating this risk were insufficient.
They also expressed concerns about the use and safety of this drug in people with kidney disease. As such, some panel members recommended that people with kidney damage do not use this drug if it is approved.
In January 2012, the FDA voted against another SGLT2 inhibitor, dapagliflozin, due to concerns about a cancer risk. This drug was approved in the European Union in November 2012. There is no cancer risk seen with canagliflozin.