FDA Approves J&J's Invokana For Treating Heart Conditions

FDA Approves J&J's Invokana For Treating Heart Conditions

Introduction

The U.S. Food and Drug Administration (FDA) approved the SGLT2 class of drug Invokana to reduce the risk of major cardiovascular (CV) events in high-risk Type 2 patients.

Global therapy area head, James List, confirmed the news stating, "this FDA approval makes Invokana the only oral type 2 diabetes treatment indicated to reduce the risk of heart attack, stroke, or CV death. It is an important step forward for patients and the physicians who treat them. Not only does Invokana enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events.”

As per the announcement, this new indication applies to the fixed-dose combinations of Invokamet tablets and Invokamet XR. Lawsuits filed against J&J over Invokana allege its use has led to amputations of legs, feet, toes, and partial scrotum, diabetic ketoacidosis, kidney failure, cardiac arrest, and urinary tract infections. As of September 2018, the multidistrict litigation (MDL No. 2750; In Re: Invokana (Canagliflozin) Products Liability Litigation) holds more than 1,100 cases over Invokana complications, which are centralized before Honorable Brian R. Martinotti in District of New Jersey for coordinated pretrial proceedings.

Currently, Johnson & Johnson faces multiple lawsuits over its talc-based products causing cancer. Hon. Freda L. Wolfson, U.S.D.J./ Hon. Lois H. Goodman, U.S.M.J. in the district court of New Jersey, is overseeing all the consolidated cases.