The drugmaker is surely hoping it fares better than its rivals AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb (NYSE:BMY) since the U.S. Food and Drug Administration turned down dapagliflozin earlier this year until more assessments of the drug can be made.
SGLT2, or sodium-glucose co-transporter 2, protein inhibitors lowers blood sugar levels by causing it to be excreted through urine. The once-a-day medication blocks protein and the return of high levels of glucose in the body and helps with weight loss.
Janssen is set to provide data from its global phase 3 study for the drug at the upcoming American Diabetes Association meeting in Philadelphia next week. The study included 10,300 patients in nine randomized trials that tested efficacy and safety.
The study included placebo- and active comparator-controlled studies, according to a company statement. The program also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease.
Janssen licensed the drug from Mitsubishi Tanabe Pharma Corp.
The SGLT2 inhibitors, which made Cleveland Clinic’s list of top medical innovations for 2012, have come under some criticism since an FDA committee voted against approving dapagliflozin in July last year over safety concerns tied to bladder cancer in phase 2b and phase 3 clinical trials.
Other diabetes treatments have fared no better. Takeda’s drug application for alogliptin, developed with Furiex, received a complete response letter from the FDA, which sent them back to do additional studies. A more comprehensive list of diabetes drugs submitted for FDA approval can be viewed here.
Still, with about 26 million Americans with diabetes today and about 366 million people globally expected to have it by 2030, there is an enormous scope for improved treatments, not to mention significant financial rewards for those who successfully develop a better drug.
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