Daewoong Pharmaceutical Co. announced on Aug. 13 that it has received U.S. Food and Drug Administration (FDA) orphan drug designation (ODD) for DWN12088, a candidate drug for patients with idiopathic pulmonary fibrosis (IPF).
DWN12088 is an oral IPF therapy with a mechanism that selectively inhibits prolyl-tRNA synthetase (PRF) protein activity and excessive production of collagen, the cause of pulmonary fibrosis. Preclinical studies have confirmed the efficacy and safety of the treatment compared to existing drugs.
Daewoong Pharmaceutical has also submitted an application for phase 1 clinical trial to the Human Research Ethics Committee (HREC) in Australia. The FDA ODD certification facilitates the development and approval of drugs for rare or refractory diseases by exempting the manufacturer from license review fees and enabling an option for priority review and seven-year monopoly after marketing authorization.
Meanwhile, 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.