Janssen seeks FDA approval for canagliflozin as Type 2 diabetes treatment

5/31/2012

RARITAN, N.J. — A Johnson & Johnson subsidiary is seeking approval for a Type 2 diabetes treatment.


Janssen Research and Development has submitted a new drug application to the Food and Drug Administration for the approval of canagliflozin — an investigational oral, once-daily, selective sodium glucose co-transporter 2 inhibitor — for use in adult patients. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels, the company said.


The filing was supported by a comprehensive global phase-3 clinical development program, which included nine multicenter, randomized clinical studies that enrolled approximately 10,300 patients. The late-stage clinical trial evaluated the safety and efficacy of canagliflozin across the spectrum of Type 2 diabetes and included placebo- and active comparator-controlled studies. The program also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease.


Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma. Janssen Pharmaceuticals has marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.




Interested in this topic? Sign up for our weekly Collaborative Care e-newsletter.

X
This ad will auto-close in 10 seconds