Daewoong Pharmaceutical Applies for Saudi Approval of Diabetes New Drug 'Enblo'

Daewoong Pharmaceutical's new diabetes drug is entering the Middle East.

N-Blo

On the 25th, Daewoong Pharmaceutical announced that it submitted a New Drug Application (NDA) for the domestically developed SGLT-2 inhibitor class diabetes treatment drug Enblo Tablets (active ingredient: Inavogliflozin) to the Saudi Food and Drug Authority (SFDA). Enblo has already completed approval submissions in four ASEAN countries. With this submission to Saudi Arabia, the company plans to accelerate its global expansion.

It marks success in entering five countries approximately 100 days after the official domestic launch. According to IQVIA, a pharmaceutical market research firm, the diabetes treatment market in Saudi Arabia was about 1.22 trillion KRW last year, making it the largest in the Middle East. Within this, the SGLT-2 inhibitor market, to which Enblo belongs, has doubled in size over two years to reach 153.4 billion KRW.

Enblo is a diabetes treatment drug developed by Daewoong Pharmaceutical, the first domestic pharmaceutical company to successfully develop a sodium-glucose cotransporter 2 (SGLT-2) inhibitor mechanism. It was launched domestically in May. Just one month after introducing Enblo to the market, approval was obtained for the metformin combination drug 'Enblomet Extended-Release Tablets 0.3/1000 mg.' Enblomet Extended-Release Tablets are scheduled for release in the second half of this year.

Enblo's efficacy and safety were validated through Phase 3 monotherapy clinical trial results, which were published in an international SCIE academic journal. Daewoong Pharmaceutical aims to make Enblo a global blockbuster drug by entering 15 countries by 2025 and 50 countries by 2030.

Daewoong Pharmaceutical CEO Seung-ho Jeon said, "This NDA submission to Saudi Arabia is a remarkable achievement within less than six months following submissions in Indonesia, the Philippines, Thailand, and Vietnam since March." He added, "We will use Saudi Arabia as a foothold to enter the Middle Eastern market and do our best to help Enblo, the 36th domestically developed new drug, grow into a global blockbuster."