Determined to build its stake in the fast-growing diabetes market, Johnson & Johnson ($JNJ) plans to showcase late-stage data this weekend on its promising SGLT2 drug candidate that has drawn both praise and skepticism from clinicians and analysts.
At the American Diabetes Association (ADA) meeting in Philadelphia, doctors and industry-watchers will be scrutinizing the data for the drug, canagliflozin, which has been linked with impressive reductions in blood sugar but has also been tied to genital infections and other issues, Bloomberg reported. An SGLT2 inhibitor, the drug is designed to remove sugar from the body through a patient's urine, a new approach to controlling blood sugar levels that might take some convincing in the clinical community.
Like all new diabetes drugs in the post-Avandia regulatory landscape, canagliflozin faces ample scrutiny of its long-term safety. Johnson & Johnson filed an NDA for the drug last month, providing U.S. regulators with an extensive data package from 9 clinical trials that included more than 10,000 patients. And the package included a study to gauge the safety of the drug in patients at risk of getting heart disease. The FDA shot down Bristol-Myers Squibb ($BMY) and AstraZeneca's ($AZN) similar drug dapagliflozin over safety worries, specifically about the risk of patients on the med developing cancer.
Cancer scares haven't cropped up in J&J's studies of canagliflozin, though many clinicians are unconvinced that the drug can be a practical and safe new way to combat Type 2 diabetes.
"Using a side effect of uncontrolled diabetes as a primary mode of treatment is unconventional, to say the least," Dr. Adrian Vella, of the Mayo Clinic in Rochester, MN, told Bloomberg. "We still need to understand how severe and how frequent the potential side effects associated with these medications are."
- check out Bloomberg's article