Daewoong Pharmaceutical recently obtained approvals for its indigenous therapies—sodium–glucose linked transporter-2 (SGLT-2) inhibitor Envlo (enavogliflozin) and its metformin combination drug Envlomet—in South Korea. As prescription trends tilt in favor of SGLT-2 combination therapies globally, the domestic innovator has an opportunity to compete with the established SGLT-2 combination therapies from multinational companies, says GlobalData, a leading data and analytics company.

With the SGLT-2 inhibitors offering concomitant cardiovascular and renal benefits, their preference has increased in the treatment algorithm of diabetes with cardiovascular and renal co-morbidities or even as preventive therapy in patients predisposed to these complications.

Moreover, the combination therapies based on one or more classes of drugs like sulfonylurea, thiazolidinedione, dipeptidyl peptidase-4 inhibitor (DPP4), sodium–glucose linked transporter-2 (SGLT-2) inhibitor, glucagon-like peptide-1 receptor (GLP-1R) agonist, and basal insulin are now recommended as first-line therapies for achieving optimal diabetes management while combinations with only SGLT-2 inhibitors, or GLP-1R agonists are recommended in diabetic patients with cardiovascular co-morbidities.

Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “With more and more younger people falling prey to diabetes and given the progressive nature of the disease, it is imperative that monotherapies may not be sustainable for long during disease management. Overtime, co-morbidities may also set in. As such, it becomes pertinent to move on to combination therapies as part of disease management in such patients refractory to monotherapies.”

According to GlobalData’s Pharma Intelligence Center, the diagnosed prevalent cases by cardiovascular comorbidity in the 16 major markets (16MM*) are expected to reach 72 million, of which more than one million cases are expected in South Korea. There are 11 marketed innovator SGLT-2 combination therapies from multinational companies available in the country.

According to the revised reimbursement standards in 2023 in South Korea, enavogliflozin can receive insurance benefits when used as a two-drug therapy with metformin.

Sahu adds: “So far, only two originator SGLT-2 and metformin combination therapies from multinational companies AstraZeneca’s Xigduo XR and MSD’s Segluromet are available in South Korea. The latest reimbursement updates in the country will give the enavogliflozin combination therapy leverage for market penetration and ensure further preference for this product, which already stands out as the first indigenous innovator SGLT2 therapy.”

Daewoong Pharmaceutical signed export contracts to Brazil and Mexico in February 2023. It plans to complete Envlo’s entry into 15 major countries, including Indonesia, the Philippines and Thailand, where it has already submitted a new drug application, by 2025, with a target to enter about 50 countries around the world by 2030.

Sahu concludes: “Strategically, Daewoong Pharmaceutical is trying to expand to various emerging international markets, thereby laying the foundation to enter the global markets. The entry of Envlo in various global markets will likely generate greater recognition and the company has the opportunity to position enavogliflozin combination therapies globally just as in South Korea.”

*16MM: Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, the UK, and the US.