Daewoong Pharmaceutical has obtained approval for SGLT2i + metformin combination drug Envlomet

Seoul [South Korea], July 19: Daewoong Pharmaceutical obtained approval for a SGLT-2 inhibitor+metformin combination drug in just one month after the release of Envlo Tab., the 1st SGLT-2 inhibitor by Korea, expanding its product portfolio.

Daewoong Pharmaceutical (Jeon Sengho and Lee Chang-jae) announced on the June 14th that Envlomet SR Tab. 0.3/1000mg, (ingredient name: enavogliflozin, metformin hydrochloride) has obtained the approval on June 13th.

Envlomet SR Tab., is a combination of two drugs, enavogliflozin and metformin hydrochloride. It has been approved as an adjuvant for dietary and exercise therapies to improve blood glucose control in patients with type 2 diabetes. Metformin is used as first-line treatment for type 2 diabetes, and enavogliflozin effectively lowers blood glucose levels with just 0.3mg, a dosage that is only 1/30 of other drugs in the same class.

Envlomet SR Tab. is a significant treatment option in the healthcare landscape where there is a growing prevalence of diabetes and the corresponding rise in the prescription of combination therapies. Combination therapies for diabetes are highly preferred and have significant market potential internationally.

Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, “We are delighted to receive the approval for Envlomet SR Tab., just one month after the release of new drug Envlo Tab., the Korea’s 1st domestic SGLT-2 inhibitor,” adding “We will continue to expand our portfolio of combination drugs, starting with Envlomet, to meet the increasing demand for such drugs in the antidiabetic drug market.”

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical’s management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical’s business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical’s products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.