The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for a supplemental New Drug Application (sNDA) for INVOKANA® (canagliflozin). The sNDA seeks a new indication for INVOKANA® to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) who have established cardiovascular (CV) disease or are at risk for CV disease. The application also applies to INVOKANA® fixed-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. Janssen announced the sNDA submission in October 2017 and with this extension the action date is now in October 2018.
INVOKANA® was approved by the FDA in March 2013 as an adjunct to diet and exercise to improve glycemic control in adults with T2D.
WHAT IS INVOKANA®?
INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.