Pharmaceutical

FDA approves new type 2 diabetes drug

diabetes illus250x03 FDA approves new type 2 diabetes drugThe Food and Drug Administration (FDA) approved Steglatro, a new type 2 diabetes drug manufactured by Merck and Pfizer.

Steglatro is in a newer class of diabetes drugs called sodium glucose transporter (SGLT) 2 inhibitors, the same class as rival drugs Invokana and Jardiance. It contains the active drug ingredient ertugliflozin, and is approved as a monotherapy in 5- and 15-milligram doses taken once daily, as well as two separate fixed-dose combinations.

One fixed dose contains the dipeptidyl peptidase (DPP) 4 inhibitor sitagliptin, and will be sold under the brand name Steglujan, in dosages of 5mg ertugliflozin/100mg sitagliptin and 15mg/100mg, each to be taken once daily. The other combination includes ertugflozin with metformin. It will be sold under the brand name Segluromet and contains either 2.5mg ertugliflozin and 500mg metformin, 2.5mg/1,000mg, 7.5mg/500mg or 7.5mg/1000mg, each to be taken twice daily.

Ertugliflozin is the fourth SGLT2 inhibitor approved in the U.S. behind canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga), and empagliflozin (Jardiance). SGLT2 inhibitors work by increasing the excretion of glucose in the urine. The most common adverse effect with these drugs is female genital mycotic infections. This side effect will also be listed on the labels of drugs containing ertugliflozin.

Since SGLT2 inhibitors hit the market in 2013, the FDA has either strengthened existing warnings or added new warnings to the safety labels of these drugs including new warnings for ketoacidosis, a serious condition in which too much acid builds up in the blood, as well as serious urinary tract infections that can lead to blood infections or kidney infections.

The FDA also added acute kidney injury warnings to Invokana and Farxiga, and required new warnings for bone fractures as well as lower limb amputations to the labels of Invokana.

In December 2016, the U.S. Judiciary Panel on Multidistrict Litigation consolidated dozens of lawsuits in New Jersey federal court alleging Invokana maker Johnson & Johnson’s Janssen Pharmaceuticals failed to warn consumers of the serious health risks associated with Invokana.

Source: Medscape