Daewoong Pharmaceutical announced on August 25 that it has submitted a new drug application (NDA) to the Saudi Food and Drug Authority (SFDA) for Envlo (enavogliflozin), a Korean-made diabetes drug belonging to the SGLT-2 inhibitor class.
According to pharmaceutical market research firm IQVIA Global MIDAS, Saudi Arabia's diabetes drug market is the largest in the Middle East, with an estimated KRW 1.22 trillion by 2022. The market for SGLT-2 inhibitors, of which Envlo is a part, is valued at KRW153.4 billion and has more than doubled in the past two years.
Envlo has completed license submissions in four ASEAN countries and will accelerate its global expansion with the submission of the Saudi Arabian license. It is about 100 days after its official launch in Korea, and it has successfully entered five countries.
Envlo is the first SGLT-2 inhibitor-based diabetes drug developed by Daewoong Pharmaceutical. Envlo, which was officially launched in Korea in May, is accelerating its expansion of its new drug lineup by obtaining approval for "Envlomet SR Tab. 0.3/1000mg" within a month of its launch. The new drug is expected to be launched in the second half of this year.
Daewoong plans to grow Envlo into a global blockbuster drug by entering 15 countries by 2025 and 50 countries by 2030.
"The application for approval in Saudi Arabia comes less than half a year after the application for approval in Indonesia, the Philippines, Thailand, and Vietnam since March," said Jeon Seung-ho, CEO of Daewoong Pharmaceutical. "We will do our best to grow Envlo, the 36th Korean made drug, into a global blockbuster by using Saudi Arabia as a bridgehead to enter the Middle East market."
