RARE Daily

FDA Grants Daewoong Fast-Track Designation for IPF Therapy

July 20, 2022

The U.S. Food and Drug Administration granted Daewoong Pharmaceutical’s experimental therapy for the rare lung condition idiopathic pulmonary fibrosis Fast Track designation.

Idiopathic pulmonary fibrosis is a lung disease, which causes the lungs to slowly harden and lose their function due to the excessive creation of fibroid tissue. It is a difficult-to-treat disease with a five-year survival rate of less than 40 percent. Treatments for this disease have failed to completely stop its progress and their treatment abandonment rate is high due to side effects, meaning there is a great medical demand that remains unmet.

DWN12088 is the world’s first Prolyl-tRNA Synthetase (PRS)-inhibiting antifibrotic drug. It reduces the effects of the PRS protein, which affects collagen creation, to inhibit excess production of collagen, the cause of fibrosis. Daewoong received FDA clearance to begin a phase 2 clinical trial in idiopathic pulmonary fibrosis last June and the agency designated DWN12088 an orphan drug in 2019. Fast Track designation was based on phase 1 results showing excellent antifibrotic effects and lung function improvement.

The FDA designates Fast Track items to promote the development and screening of drugs that can meet the currently unmet medical demands and treat severe diseases. Drugs approved for Fast Track designation are developed with close collaboration with the FDA at each stage of the development process, including consultation on clinical trial design and advice on data collected. Accelerated approval and priority review can also be requested once the second phase is complete, meaning Daewoong’s idiopathic pulmonary fibrosis treatment DWN12088 could be developed more quickly.

Author: Rare Daily Staff

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