Daewoong Pharmaceutical said that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) for DWN12088 that treats systemic scleroderma.

Daewoong's fibrosis treatment has won additional orphan drug status from the U.S. FDA. (Daewoong)
Daewoong's fibrosis treatment has won additional orphan drug status from the U.S. FDA. (Daewoong)

The designation comes after the drug won an ODD status to treat idiopathic pulmonary fibrosis (IPF) in August 2019.

Systemic scleroderma is a disease in which the body's skin begins to harden from the fingertips to the lungs, heart, and other major organs due to an excessive collagen intake in the body. The illness currently has no treatments available.

Daewoong expects DWN12088 will effectively treat systemic sclerosis as DWN12088 is an oral therapy with a mechanism that selectively inhibits Prolyl-tRNA Synthetase (PRS) protein activity and excessive production of collagen.

“Daewoong has confirmed the potential of DWN12088 as a treatment for systemic sclerosis through non-clinical tests," the company said. "If approved, it will be the world's first systemic sclerosis therapy."

Daewoong Pharmaceutical CEO Jeon Seng-ho said, "We are developing DWN12088 as the world's first fibrosis treatment that inhibits the production of PRS protein."

Jeon added that the company would contribute to treating rare diseases by developing the drug as a treatment for fibrosis that can occur in various organs.

FDA's ODD is a system that helps smooth the development and approval of therapeutic drugs for rare or life-threatening diseases. ODD drugs receive tax benefits, exemption of license application fees, and a seven-year monopoly after obtaining authorization.

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