Daewoong Pharmaceutical’s new drug for pulmonary fibrosis, DWN12088, selected by the U.S. FDA Orphan Drug Designation.

Daewoong Pharmaceutical’s new drug for pulmonary fibrosis, DWN12088, selected by the U.S. FDA Orphan Drug Designation. - The world’s first-in-class PRS inhibitor selected for Orphan Drug Designation for idiopathic pulmonary fibrosis. - Granted waiver of new drug review fees, rights to priority review, and exclusive rights for seven years. Daewoong Pharmaceutical (CEO Sengho Jeon) announced on the 13th that DWN12088, the world’s first-in-class PRS (Prolyl-tRNA Synthetase) inhibitor for the rare incurable idiopathic pulmonary fibrosis, was selected by the U.S. FDA’s Orphan Drug Designation last 8th. FDA’s Orphan Drug Designation (ODD) is a system that sponsors the development and approval of drugs for rare incurable diseases and the drugs with ODD approval enjoy benefits such as waiver of new drug inspection fees, rights to priority review, and exclusive rights for seven years. ‘DWN12088’ is an oral drug for fibrosis that selective decreases the activation of PRS protein to inhibit excess generation of collagen that causes pulmonary fibrosis.  It has proven improved efficacies and safety compared to the existing drugs in the animal models with pulmonary fibrosis through pre-clinical studies and the plans for clinical study phase 1 have been submitted to the Human Research Ethics Committee (HREC) in Australia. Idiopathic pulmonary fibrosis is one of the interstitial pulmonary diseases where the lungs slowly harden to lose function.  It is a rare disease that is difficult to cure with less than 40% survival rate in five years after diagnosis. “DWN12088 is the world’s first drug on fibrosis for the new target of PRS and the FDA’s Orphan Drug Designation is expected to support our development of a safe drug for the patients who are suffering from pulmonary fibrosis faster,” said CEO Sengho Jeon of Daewoong Pharmaceutical.  “Daewoong Pharmaceutical will expand studies in various fibrosis diseases that affect the skin, kidney, liver, and heart and strengthen our R&D department on rare diseases.” DWN12088 was also selected for Korea Drug Development Fund’s sponsorship for new drug development last February due to the needs to develop drugs for fibrosis diseases. #   #   #

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