Daewoong Pharmaceutical's diabetes drug Envlo (enavogliflozin) has received product approval from the Ecuadorian health authority, ARCSA, in September 2024. This marks the first approval for Envlo outside of South Korea, where it was initially launched in May 2023.
Envlo is a first-in-class sodium-glucose co-transporter-2 (SGLT-2) inhibitor developed in South Korea. With this approval, Daewoong plans to launch Envlo in Ecuador in the first half of 2025, aiming to expand its presence in the Central and South American market.
Expansion Plans
Daewoong Pharmaceutical has been actively pursuing regulatory approvals in other countries. The company previously passed the Good Manufacturing Practice (GMP) quality management review by the Brazilian Health Regulatory Agency (ANVISA) in November 2023. Applications for product approvals have been submitted in Mexico, Peru, and Colombia.
Furthermore, Daewoong has submitted product approval applications in a total of 12 countries, including Saudi Arabia, Indonesia, Thailand, the Philippines, Vietnam, and Malaysia. Cooperation agreements have been established with eight countries, including Mexico and Russia. The company aims to expand its reach to 15 countries by next year and 30 countries by 2030.
Executive Perspective
"The acquisition of the first product approval in Ecuador is an important achievement in our global rapid entry strategy," said Chief Executive Officer Park Seong-soo, emphasizing the company's commitment to bringing innovative treatment options to diabetes patients worldwide.
