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Invokamet

Generic name: canagliflozin and metformin
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction

Update: Invokamet (canagliflozin and metformin) Now FDA Approved - August 8, 2014

FDA Issues Complete Response Letter for Canagliflozin/Metformin Fixed-Dose Combination Therapy for Type 2 Diabetes

RARITAN, N.J., Dec. 12, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has received from the U.S. Food and Drug Administration (FDA) a complete response letter regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes.

The complete response letter related to the NDA requested additional information to support the comparability of the twice-daily dosing regimen of canagliflozin -- as part of the canagliflozin and metformin FDC -- and the once-daily dosing of canagliflozin as a single agent. Janssen believes it can supply this information based on available clinical data from the comprehensive Phase 3 clinical development program for canagliflozin.

"We continue to have productive discussions with the FDA and will work closely with the agency to advance this application," said Norman Rosenthal, MD, FACE, FACP, canagliflozin compound development team leader, Janssen Research & Development, LLC. "We look forward to addressing questions from the FDA as soon as possible and remain committed to providing therapeutic options that meet the needs of the type 2 diabetes community."

Canagliflozin is an oral medication that selectively inhibits sodium glucose co-transporter 2 (SGLT2), a carrier responsible for the reabsorption of glucose by the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes. Metformin is a first-line oral medication that can be used alone or with other medications, including insulin, to treat type 2 diabetes. Metformin lowers blood glucose levels by decreasing the amount of glucose made by the liver.

If approved, the canagliflozin and metformin fixed-dose combination could provide convenience for patients who may benefit from the two diabetes medications in one tablet. Janssen announced the submission of the canagliflozin/metformin fixed-dose combination therapy NDA on December 12, 2012.

In March of this year, the FDA approved canagliflozin (INVOKANA®) as a single agent as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® has since been widely adopted and today it is the number one branded therapy prescribed by U.S. endocrinologists when adding or switching non-insulin type 2 diabetes medications.

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.

SOURCE Janssen Research & Development, LLC Read more: http://www.digitaljournal.com/pr/1638736#ixzz2nJlheZ1N

Posted: December 2013

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