FDA Approves New Type 2 Diabetes Drug Ertugliflozin in the US

A new SGLT2 inhibitor drug has been approved to treat type 2 diabetes by the US Food and Drug Administration (FDA). With metformin and Januvia (sitagliptin) in combination, ertugliflozin was approved both as a single treatment and following successful from two phase III trials prior this year.

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), STEGLATRO (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN (ertugliflozin and sitagliptin) tablets.

The drug has been developed by drug companies Merck and Pfizer and is currently under review for approval in Europe by the European Medicines Agency. In the VERTIS MET and VERTIS SITA trials, ertugliflozin was shown to enhance blood sugar control and meet its primary results.

VERTIS MET was a 26-week examines which assessed the safety and effectiveness of 5mg and 15mg ertugliflozin in combination with metformin, contrasted with placebo and metformin, among 464 adults with poorly controlled type 2 diabetes taking just metformin.

Those taking the ertugliflozin combination had lower HbA1c levels; lower blood glucose levels lost more weight and had a lower pulse.

In the VERTIS SITA trial, the same dosages of ertugliflozin were tested in combination with Januvia, compared to placebo and Januvia, with similar outcomes observed.

In the US under the brand names Steglujan, the safety profile of ertugliflozin, which will now be available and Segluromet was consistent with other SGLT2 drugs.

“As the worldwide burden of diabetes continues on rising, we are focused on meeting patients’ needs with additional treatment options to help manage their condition,” said James Rusnak, MD, PhD, chief development officer for cardiovascular and metabolic diseases, Pfizer Global Product Development, who added the examination discoveries “underscore the potential of ertugliflozin as a vital therapeutic option ” for adults with type 2 diabetes.

The treatments are relied upon to be made available in the US in early 2018.


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