Daewoong Pharmaceutical Applies for MFDS Approval of Diabetes New Drug 'Inavogliflozin'

The Nation's First SGLT-2 Inhibitor Mechanism
Domestic Approval Targeted for Second Half, Launch Planned for First Half of Next Year

Daewoong Pharmaceutical exterior.

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 1st that it has completed the application and submission for the marketing authorization of the new diabetes drug Enavogliflozin to the Ministry of Food and Drug Safety.

This marketing authorization application was made based on the results of Phase 3 clinical trials of Enavogliflozin, a new diabetes drug with the mechanism of SGLT-2 (sodium-glucose co-transporter) inhibitor, both as monotherapy and combination therapy.

Daewoong Pharmaceutical disclosed in the first quarter the topline results of the Phase 3 clinical trial, confirming statistical significance in the change of glycated hemoglobin (HbA1c) in monotherapy and demonstrating non-inferiority and safety in combination therapy. Glycated hemoglobin is formed when hemoglobin is exposed to high blood glucose levels and is used as an indicator of average blood sugar, serving as an important marker directly related to diabetic complications.

Daewoong Pharmaceutical plans to obtain domestic approval for Enavogliflozin in the second half of this year and launch both the single agent and combination products in the first half of next year. In January, Daewoong Pharmaceutical received approval from the Ministry of Food and Drug Safety for a Phase 1 clinical trial of a combination drug adding metformin to Enavogliflozin. Additionally, to expand Enavogliflozin globally, it obtained approval for a Phase 3 clinical trial of the single agent in China in February, and plans to submit overseas marketing authorization applications (NDA) for Enavogliflozin, starting with countries where it has overseas branches and subsidiaries.

Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, “By completing the approval process this year and launching Enavogliflozin in the market next year, Daewoong Pharmaceutical will become the first company in Korea to develop a new diabetes drug in the SGLT-2 inhibitor class,” adding, “We will fulfill the social responsibility of a pharmaceutical company by realizing ‘medical patriotism’ through providing the best new drug to diabetes patients.”

This content was produced with the assistance of AI translation services.