Daewoong seeks permit for Korea's 1st homegrown SGLT2 diabetes drug Envlo in Mexico

Daewoong Pharmaceutical said that it applied for product approval for Envlo, the first homegrown sodium-glucose cotransporter 2 (SGLT2) diabetes drug in Korea and the nation's 36th newly developed drug, to Mexico's Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS).

COFEPRIS is responsible for regulating a variety of health-related topics in Mexico, including food safety, pharmaceutical drugs, medical devices, organ transplants, and environmental protection.

The application utilizes clinical data from Korea, allowing the company to forego additional clinical trials in Mexico.

Envlo is intended to improve glycemic control in patients with type 2 diabetes and is administered alongside diet and exercise regimens. It has demonstrated non-inferiority to existing treatments through various clinical trials, including monotherapy and combination therapies.

Daewoong had previously highlighted several advantages of Envlo over existing SGLT-2 inhibitors, including a reduced dose that still achieves significant reductions in glycated hemoglobin (a decrease of about 1 percent compared to placebo) and a high rate of achieving target blood sugar levels (HbA1c<7%) in approximately 70 percent of cases.

Additionally, Envlo has shown improvements in cardiovascular risk factors such as weight, blood pressure, and lipid levels, supported by extensive clinical data involving Korean patients.

In pursuit of transforming Envlo into a global blockbuster drug, Daewoong has been actively seeking to enter international markets. Following applications in Indonesia, the Philippines, Thailand, and Vietnam last year, and more recently in Saudi Arabia, the company is now targeting the Latin American market with its latest move in Mexico.

Prior to this application, Daewoong had already secured export contracts for Brazil and Mexico, including an agreement with Mexico's Moksha8 in February of last year.

The company anticipates substantial sales from these markets, expecting about 37.6 billion won ($27.7 million) from Mexico alone, contributing to an overall contract value exceeding 100 billion won.

"The expected acquisition of a local approval in Mexico for the type 2 diabetes drug Envlo, the first new drug to be developed in Korea that inhibits SGLT2, will contribute to the full-scale entry of the drug into Latin America and expansion of overseas sales," the company said.