Daewoong Pharmaceutical said on Aug. 13 that it received orphan drug designation (ODD) for its First-in-Class PRS(Prolyl-tRNA Synthetase) DWN12088, a drug to treat patients with idiopathic pulmonary fibrosis (IPF) from the U.S. Food and Drug Administration (FDA) on Aug. 8.
The FDA's designation of ODD is a system that supports the development and approval of treatments for rare and incurable diseases. The ODD-approved medicine will be granted benefits such as exemption from the costs of screening new drug licenses, the right to apply for a priority review, and the recognition of exclusive rights for seven years upon approval of a marketing license.
"DWN12088" is an oral fibrosis treatment with a mechanism that selectively reduces the activity of the PRS protein to suppress the excessive production of collagen that causes pulmonary fibrosis. It has submitted a clinical first-phase test plan to the Human Research Ethics Committee (HREC) of Australia.
IPF is one of the interstital lung diseases in which lung function is lost as the lungs slowly harden, and is a rare disease known for its difficult treatment and the five-year survival rate of less than 40 percent after diagnosis.
"DWN12088 is the world's first fibrosis medicine under development by Daewoong Pharmaceutical on its new target of PRS, and we expect the FDA's designation to help our company develop a safer drug for patients suffering from pulmonary fibrosis more quickly," said Daewoong Pharmaceutical CEO Jeon Seung-ho.
Meanwhile, in February, DWN12088 was selected as the target of support for the new drug development section of the pan-ministerial new drug development business corps in recognition of the need to develop drugs for fibrosis diseases in Korea.