Breaking News
FONT-SIZE Plus   Neg
Share SHARE

FDA Approves J&J' New Diabetes Drug INVOKANA Or Canagliflozin

RELATED NEWS
Trade JNJ now with 

Johnson & Johnson (JNJ: Quote) company Janssen Pharmaceuticals, Inc. announced the U.S. FDA approval for INVOKANA or canagliflozin tablets for the treatment of adults with type 2 diabetes. INVOKANA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

According to the FDA, Type 2 diabetes is the most common form of the disease, affecting about 24 million people and accounting for more than 90 percent of diabetes cases diagnosed in the U.S.

"Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.

Janssen noted that the global Phase 3 clinical program, which enrolled 10,285 patients in nine studies, showed that the 100 mg and the 300 mg doses of INVOKANA improved glycemic control and, in prespecified secondary endpoints, were associated with significant reductions in body weight and systolic blood pressure.

Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels.

Jimmy Ren, Ph.D., Therapeutic Area Lead, Metabolics, Medical Affairs, Janssen Pharmaceuticals, Inc., stated, "INVOKANA provides patients with type 2 diabetes the option of a once-daily oral therapy that offers improved glycemic control and, in Phase 3 studies, showed an incidence of hypoglycemia - low blood glucose - that was lower than with glimepiride and similar to that of sitagliptin,"

The FDA specified that the most common side effects of Invokana are vaginal yeast infection (vulvovaginal candidiasis) and urinary tract infection.

Janssen plans to partner with other Johnson & Johnson companies focused on diabetes to bring the product to healthcare professionals treating patients with diabetes.

JNJ closed Thursday's regular trading session at $81.53.

Register
To receive FREE breaking news email alerts for Johnson & Johnson and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Stocks moved notably higher over the course of the trading day on Friday after initially showing a lack of direction. The gains on the day extended the recent upward trend by the markets, with the tech-heavy Nasdaq reaching its best closing level in almost a month. Looking to capitalize on news of an Ebola diagnosis in New York City, Republican Senate candidate Scott Brown issued a statement Friday criticizing his Democratic opponent Sen. Jeanne Shaheen, D-N.H., for "waffling" on a travel ban. In another troubling sign for Democrats, the results of a Gallup poll released on Friday show that Tea Party Republicans are much more motivated to vote in the upcoming midterm elections than other Americans. The poll found that 73 percent of Tea Party Republicans are "extremely" or "very" motivated to vote in this year's elections.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.