The U.S. Food and Drug Administration (FDA) has designated Daewoong Pharmaceutical's DWN12088 as Orphan Drug for Systemic Sclerosis.
This is the second time that DWN12088 has been designated as an orphan drug. The FDA designated it as an orphan drug for idiopathic pulmonary fibrosis (IPF) in 2019.
Systemic Sclerosis is a disease in which the skin of the whole body begins to harden and later hardens to major organs such as the lungs and heart. To date, no drugs have been licensed for the treatment of Systemic Sclerosis.
Daewoong Pharmaceutical is also developing DWN12088 as a treatment for Systemic Sclerosis, believing that tissues and organs become stiff due to an excessive increase in collagen in the body.
To date, nonclinical tests have been conducted to confirm the possibility as a treatment for Systemic Sclerosis. In the future, if DWN12088 is licensed as a treatment, it is expected to be able to treat Systemic Sclerosis for the first time in the world and even treat Interstitial Lung Disease (ILD) with Systemic Sclerosis.
"We are developing DWN12088 for the first time in the world as a Pulmonary Fibrosis treatment that inhibits the production of Prolyl-tRNA Synthetase (PRS) proteins," said Jeon Seung-ho, president of Daewoong Pharmaceutical. "We have also achieved a feat of being designated as Orphan Drug for Systemic Sclerosis. Daewoong Pharm will continue to develop various treatments to give hope to patients suffering from rare diseases."
