18 July 2018 - - The US Food and Drug Administration has extended the review timeline for Janssen Pharmaceutical Companies' supplemental New Drug Application (sNDA) for Invokana (canagliflozin), the company said.
The sNDA seeks a new indication for Invokana to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes T2D who have established cardiovascular disease or are at risk for CV disease. The application also applies to Invokanafixed-dose combinations, INVOKAMET and INVOKAMET XR, and is based on data from the Phase 3 CANVAS Program.
The FDA has requested a three-month extension to provide additional time to complete the review of the application after the agency requested and received additional analyses from the company. The action date is now in October 2018.
Invokana, approved as an adjunct to diet and exercise to improve glycemic control in adults with T2D, is a prescription medicine used along with diet and exercise to lower blood sugar in adults with T2D.
The Janssen Pharmaceutical Companies, a segment of US-based global healthcare company Johnson and Johnson (NYSE: JNJ), work to find new and better ways to prevent, intercept, treat, and cure disease. The pharmaceutical segment offers various products in the areas of immunology, infectious diseases and vaccines, neuroscience, oncology, and cardiovascular and metabolic diseases.