Daewoong Pharmaceutical said it obtained local marketing approval for Envlomet Sustained Release' (pipeline: DWJ1525), a combination drug mixing the domestic SGLT-2 inhibitor Envlo Tab. (ingredient: enavogliflozin) with metformin, a first-line treatment for diabetes.

The Ministry of Food and Drug Safety (MFDS) granted the approval on Tuesday for Envlomet Sustained Release Tab. 0.3/1000mg (enavogliflozin and metformin hydrochloride). The approved indication is type 2 diabetes mellitus for which the combination of enavogliflozin and metformin is suitable.

At the time of the domestic approval of Envlo at the end of last year, the indication for the combination of Envlo and metformin was also approved. Thus, the combo drug of the two ingredients was approved as a drug required for data submission.

In January 2022, Daewoong received regulatory approval to conduct a phase 1 clinical trial to evaluate the pharmacokinetic characteristics and safety of enavogliflozin and metformin combo drug (DWJ1525) alone and the combination of enavogliflozin (DWP16001) and metformin (DWC202101).

Daewoong plans to launch Envlomet in the second half of this year. The company developed the combo to improve patient convenience, it said. 

The Korean market for SGLT-2 inhibitors and metformin combinations is estimated at about 50 billion won ($39.1 million). 

Daewoong is also developing a three-drug combination product that combines enavogliflozin, metformin, and a DPP-4 inhibitor. 

The DPP-4 inhibitor component for which Daewoong has been approved for the three-drug combination is gemigliptin, whose original drug is owned by LG Chem.

Envlo Tab. is the 36th novel drug in Korea and the first SGLT-2 inhibitor developed by a domestic pharmaceutical company. 

Daewoong launched the treatment in May with health insurance coverage. 

The company said it would increase sales of Envlo to 100 billion won within three years.

According to UBIST, domestic prescriptions for SGLT-2 inhibitors, both monotherapy and combination, were valued at 182.6 billion won in 2022.