FDA approves Janssen’s Invokana for type 2 diabetes
The FDA has approved Janssen Pharmaceuticals’ Invokana (canagliflozin) for the treatment of adults with type 2 diabetes.
Invokana is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the U.S. It is also the only oral, once-daily medication available in the U.S. offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trials.
“Patients with type 2 diabetes struggle managing their blood sugar, and nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, increasing their risks for potentially life-threatening complications,” said Richard Aguilar, M.D., medical director, Diabetes Nation and Diabetes Care Foundation, a non-profit organization committed to improving diabetes care. "Invokana is thought to work differently than other currently-available medicines because it reduces blood glucose by acting on the kidneys as a ‘glucuretic,’ increasing the loss of glucose in the urine. What has historically been viewed as a sign of diabetes—glucose in the urine—may also reflect the efficacy of a new and unique approach to treatment.”
The new drug application for Invokana was based on a comprehensive global phase III clinical program, which enrolled 10,285 patients in nine studies and is one of the largest clinical programs in type 2 diabetes submitted to health authorities to date.
Results from this program showed that the 100mg and the 300mg doses of Invokana improved glycemic control and, in prespecified secondary endpoints, were associated with significant reductions in body weight and systolic blood pressure. In two studies comparing Invokana to current standard treatments—one studying sitagliptin and the other studying glimepiride—Invokana dosed at 300mg provided greater reductions in A1C levels and body weight than either comparator. In the two studies, the overall incidence of adverse events was similar with Invokana and the comparators.
In studies of Invokana as monotherapy or in combination with agents not associated with hypoglycemia (such as metformin or metformin and pioglitazone), the incidence of hypoglycemic episodes were less than 5% across the groups (Invokana 100mg [3.8%], Invokana 300mg [4.3%], and placebo [2.2%]). There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Invokana or any other antidiabetic medication. Additional data are being collected to further characterize the cardiovascular profile of Invokana.