FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of Adults with Type 2 Diabetes
RARITAN, NJ, January 10, 2013 – Janssen Research & Development, LLC (Janssen) announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10 – 5 to recommend approval for canagliflozin, proposed trade name INVOKANA™, to treat type 2 diabetes in adult patients based on the efficacy and safety results from its comprehensive clinical development program.
Source: press release, 1/10/13. http://www.jnj.com/connect/news/product/fda-advisory-committee-recommend...
January 10, 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
The committee will discuss new drug application (NDA) 204042, canagliflozin tablets, proposed trade name INVOKANA, submitted by Janssen Research and Development, LLC. Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting
Source: FDA.gov. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm331503.htm