Daewoong Pharma said it has submitted a New Drug Application (NDA) to the Saudi Food and Drug Authority (SFDA) for Envlo tablets (ingredient: enavogliflozin), a diabetes treatment and Korea's 36th new drug.

The treatment is the first locally developed sodium-glucose cotransporter 2 (SGLT-2) inhibitor.

According to IQVIA, a global drug market research firm, Saudi Arabia's diabetes drug market size was worth 1.22 trillion won ($919.5 million) in 2022, making it the largest in the Middle East. The market for SGLT-2 inhibitors, of which Envlo is a part, is valued at 153.4 billion won and has grown more than twofold since 2020.

Apart from Saudi Arabia, Daewoong has also completed the NDA for Envlo in four Association of Southeast Asian Nations (ASEAN) countries – Indonesia, Thailand, the Philippines, and Vietnam -- and will continue to accelerate its global expansion with the goal of entering 15 countries by 2025 and 50 countries by 2030.

"The Saudi Arabia approval submission for Envlo comes less than half a year after the company applied for approval in Indonesia, Philippines, Thailand, and Vietnam in March," Daewoong Pharma CEO Jeon Seng-ho said. "We will do our best to make Saudi Arabia a bridgehead for entering the Middle East market and grow Envlo into a global blockbuster drug."