Daewoong Pharmaceutical said that the U.S. Food and Drug Administration has granted an orphan drug designation (ODD) to DWN12088, idiopathic pulmonary fibrosis (IPF) treatment candidate.
|Daewoong's headquarters in Samsung-dong, southern Seoul.|
FDA's ODD is a system that helps smoothe the development and approval of therapeutic drugs for rare or life-threatening diseases. ODD drugs receive tax benefits, exemption of license application fees, and seven-year monopoly after obtaining authorization.
DWN12088 is an oral IPF therapy with a mechanism that selectively inhibits Prolyl-tRNA Synthetase (PRF) protein activity and excessive production of collagen.
Preclinical studies have confirmed the efficacy and safety of the treatment compared to existing drugs, and the company has also submitted phase 1 clinical trial to the Human Research Ethics Committee (HREC) in Australia
IPF is an interstitial lung disease, in which the lung gradually hardens and loses its function. It is a rare disease that is difficult to treat and has a five-year survival rate of less than 40 percent.
"DWN12088 is the world's first IPF treatment that targets PRS," Daewoong Pharmaceutical CEO Jeon Seng-ho said. "With the ODD, the company expects to develop the treatment faster for patients suffering from IPF."