Janssen's Invokamet Approved for Type 2 Diabetes
Janssen Pharmaceuticals has launched Invokamet in the U.S., following the FDA approval of the type 2 diabetes therapy. The product is the first fixed-dose combination of an SGLT2 inhibitor plus metformin cleared for marketing in the U.S.
Invokamet, which combines canagliflozin and metformin into a single tablet, is indicated for glycemic control, along with diet and exercise, in patients with type 2 diabetes mellitus who are taking both drugs as monotherapies or have not responded well to either taken alone.
Canagliflozin works with the kidney to excrete glucose in the urine, while metformin decreases the production of glucose in the liver and improves the body’s response to insulin, providing an effect that is longer lasting than other diabetes drug-metformin combinations, said Janssen spokesman Jimmy Ren. Canagliflozin also aids in weight loss and reducing blood pressure, two important elements in diabetes control, he said.
A myriad of Phase III trials have borne this out. Janssen studied Invokamet in 4,732 patients on canagliflozin with metformin, metformin plus another diabetes drug or metformin alone and found the canaglifozin/metformin combination outperformed the alternatives in lowering blood sugar, weight loss and systolic blood pressure.
The drug’s label includes a boxed warning, however, for lactic acidosis, a rare but severe complication caused when too much metformin accumulates in the body.
Janssen’s Invokana (canagliflozin) was approved as a monotherapy in March 2013. The company estimates that up to 95 percent of the roughly 29 million diabetics in the U.S. have the type 2 form of the disease. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.