The Korean government has approved MSD’s Steglatro (ingredient: ertugliflozin l-pyroglutamic acids), the nation’s fifth sodium-glucose transport protein 2 (SGLT-2) inhibitor.

The Ministry of Food and Drug Safety said it gave the nod to MSD Korea to sell the tablet as of Friday. Developed jointly by MSD and Pfizer, Steglatro is used as an aid to diet and exercise to improve blood sugar control in adults with type-2 diabetes.

MSD’s antidiabetic drug Steglatro

The approved doses are 5 mg and 15 mg. Like other SGLT-2 inhibitors, Steglatro cannot be given to patients with severe renal impairment or end-stage renal disease and dialysis patients.

MSD Korea obtained Steglatro’s indications for both monotherapy and combination therapy with metformin and sitagliptin.

In clinical trials, Steglatro significantly reduced the glycosylated hemoglobin levels in monotherapy or combination with sitagliptin (brand name: Januvia)

In a study of 463 patients with type-2 diabetes (baseline A1C 7.0-10.5 percent) who failed to reach the target blood glucose levels with metformin and sitagliptin, the patient group who additionally took Steglatro with metformin and sitagliptin lost weight compared to patients who received placebo. The combo therapy group also showed meaningful improvement in plasma glucose and blood pressure.

Steglastro is a follow-up drug from MSD, which released a revolutionary antidiabetic treatment Januvia, a DPP-4 (dipeptidyl peptidase-4) inhibitor.

In December 2017, the pharmaceutical firm won the U.S. Food and Drug Administration’s approval simultaneously for Steglatro, Steglatro+sitagliptin combo Steglujan, and Steglatro+metformin combo Segluromet.

Although the local approval only applies to Steglatro only, the drugmaker is likely to obtain the nod for combination treatments soon, observers said.

lhs@docdocdoc.co.kr

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