Development Period Likely to Be Shortened
Daewoong Pharmaceutical announced on July 19 that its drug for idiopathic pulmonary fibrosis, dubbed DWN12088, has been granted fast-track designation by the U.S. Food and Drug Administration (FDA).
The designation will allow Daewoong Pharmaceutical to accelerate the development of DWN12088. The company plans to move into the rapidly growing global idiopathic pulmonary fibrosis treatment market as early as possible.
Idiopathic pulmonary fibrosis is a lung disease in which the lungs gradually become stiff and lose their functions due to inordinately produced fibrous tissues. The rare disease is difficult to treat and has a five-year survival rate of less than 40 percent after diagnosis.
DWN12088 is the world’s first Prolyl-tRNASynthetase (PRS) inhibitory antifibrotic drug under development by Daewoong. It has a mechanism of suppressing the excessive production of collagen that causes fibrosis by enervating PRS protein that affects collagen production. DWN12088 received phase 2 investigational new drug (IND) approval for the treatment of idiopathic pulmonary fibrosis in June of this year and orphan drug designation in 2019.