Daewoong, First Domestic Idiopathic Pulmonary Fibrosis New Drug Designated for FDA Fast Track

[Asia Economy Reporter Chunhee Lee] Daewoong Pharmaceutical's 'DWN12088,' the world's first-in-class innovative drug under development for idiopathic pulmonary fibrosis, has been designated as a Fast Track development item by the U.S. Food and Drug Administration (FDA). This is the first case in Korea, where multiple pharmaceutical companies are challenging the development of new drugs for idiopathic pulmonary fibrosis.

DWN12088 is the world's first PRS inhibitor anti-fibrotic drug independently developed by Daewoong Pharmaceutical. It has a mechanism that reduces the action of the PRS protein, which affects collagen production, thereby inhibiting the excessive production of collagen that causes fibrosis. In June, DWN12088 received FDA approval for Phase 2 IND for idiopathic pulmonary fibrosis. It was also designated as an orphan drug in 2019.

Idiopathic pulmonary fibrosis is a lung disease in which the lungs gradually harden and lose function due to excessively produced fibrous tissue. It is known as a rare incurable disease with a survival rate of less than 40% five years after diagnosis. Although treatments developed by multinational pharmaceutical companies are currently on the market, they cannot stop the progression of the disease itself, and the dropout rate due to side effects is high, so there remains a high level of unmet medical needs. Meanwhile, the market size is expected to continue growing. According to the global market research firm Research and Markets, the idiopathic pulmonary fibrosis treatment market is expected to grow at a high annual rate of 7% and reach $6.1 billion (approximately 8 trillion KRW) by 2030.

Daewoong Pharmaceutical plans to quickly enter the rapidly growing global idiopathic pulmonary fibrosis treatment market and become a game changer in this field, leveraging the Fast Track designation. Drugs designated as Fast Track can have close consultations with the FDA at each stage of development, including advice on clinical trial design and review of acquired data during the approval process. After Phase 2, applications for 'Accelerated Approval' and 'Priority Review' are also possible, which is expected to accelerate the development speed of DWN12088.

The FDA designates Fast Track status to promote the development and review of drugs that treat serious diseases and address unmet medical needs. DWN12088 was designated as Fast Track based on nonclinical studies showing excellent anti-fibrotic and lung function improvement effects and Phase 1 clinical trial results in healthy subjects, generating significant global expectations and interest going forward.

Seungho Jeon, CEO of Daewoong Pharmaceutical, said, “Idiopathic pulmonary fibrosis is a disease with high unmet medical needs despite existing treatments. We will work closely with the FDA and accelerate development to commercialize this innovative drug as soon as possible.”

This content was produced with the assistance of AI translation services.