Daewoong Pharmaceutical said on the 27th that Envlo 0.3 mg (ingredient name inavogliflozin), a type 2 diabetes treatment, has obtained marketing approval in Mexico.
Daewoong Pharmaceutical applied for marketing approval in 12 Latin American countries and, including Mexico, a key market in the region, has so far received approvals in seven countries. In particular, these 12 countries account for more than 90% of Latin America's total economy, and the company expects to effectively gain a first-mover advantage in major markets. The company plans to gradually expand the rollout of Envlo across Latin America starting this year.
The Latin American diabetes drug market is valued at several billion dollars a year and is seen as a high-growth market. According to the International Diabetes Federation (IDF), the number of people with diabetes is rising rapidly in Latin America, including Mexico, due to urbanization, an increase in obesity, and the spread of high-calorie diets. Mexico is also among the countries in Latin America with a high prevalence of diabetes.
Envlo is a domestically developed new drug in the SGLT-2 inhibitor class created by Daewoong Pharmaceutical. It works by lowering blood sugar through a mechanism that inhibits renal glucose reabsorption. Beyond glucose-lowering, this class is drawing attention for therapeutic benefits in heart failure and kidney disease.
According to Daewoong Pharmaceutical, Envlo demonstrated equal or superior glucose-lowering efficacy even at a low dose of 0.3 mg, about one-thirtieth of existing global SGLT-2 inhibitors. It also showed effects on weight loss and blood pressure improvement.
In a patient group with diabetes accompanied by reduced kidney function, improvements were observed in ▲ urine glucose-to-creatinine ratio (UGCR) ▲ fatty liver index ▲ insulin resistance index (HOMA-IR). The company said positive changes were also seen in albuminuria and the cardiac stress marker (NT-proBNP).
Park Sung-soo, CEO of Daewoong Pharmaceutical, said, "This approval in Mexico is the first result of our strategy to expand in Latin America," adding, "We will accelerate commercialization in Mexico based on our local partner's network and regulatory response capabilities, and we will expand the supply of Envlo across Latin America in the future."