The Food and Drug Administration (FDA) has accepted three New Drug Applications (NDAs) from Merck and Pfizer Inc., for drugs containing ertugliflozin, a new medication from a class of diabetes drugs known as SGLT2 inhibitors. The three NDAs include an ertugliflozin only treatment, a fixed-dose combination of ertugliflozin and the diabetes drug Januvia (sitagliptin), and a fixed-dose combination of ertugliflozin and the first-line diabetes drug metformin.
The FDA is expected to review the medication in December 2017. Additionally, the European Medicines Agency (EMA) has also agreed to review three drug applications containing ertugliflozin. The applications are supported by studies comprised of nine Phase 3 clinical trials involving 12,600 adults with type 2 diabetes.
SGLT2 inhibitors first hit the market in 2013 with the introduction of Johnson & Johnson’s Janssen Pharmaceuticals’ Invokana, now a blockbuster type 2 diabetes treatment. Since its approval, the FDA has strengthened or added new warnings to Invokana as well as some other SGLT2 inhibitors. Those warnings include an increased risk of serious urinary tract infections, bone mineral density loss, bone fractures, acute kidney injury and ketoacidosis, a condition in which too much acid builds up in the blood.
Consumers who have been treated with Invokana and suffered from serious injuries, including kidney damage and ketoacidosis, have filed lawsuits against Janssen Pharmaceuticals accusing the drug maker of not adequately warning of Invokana side effects.