MFDS Approves New Idiopathic Pulmonary Fibrosis Drug 'Jascayd'
Antifibrotic and anti-inflammatory effects expected
Expedited review supports its introduction in Korea
The Ministry of Food and Drug Safety said it approved Jascayd tablets (active ingredient: nerandomilast), an imported orphan drug used to treat idiopathic pulmonary fibrosis, on October 15.
The drug selectively inhibits phosphodiesterase 4, reducing the expression of fibrosis-inducing growth factors and inflammation-related substances that are overexpressed in fibrotic lung disease. It is a treatment for idiopathic pulmonary fibrosis with antifibrotic and anti-inflammatory effects.
The Ministry designated the drug as the 16th product under its Global Innovative Products on Fast Track (GIFT) support program and conducted an expedited review to help bring it to medical settings quickly.
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The Ministry said, "We expect the drug to provide new treatment opportunities for patients with idiopathic pulmonary fibrosis through a mechanism of action different from that of existing treatments." It added, "We will continue to do our utmost to expand patients' treatment options by expediting the review and approval of treatments whose safety and efficacy have been sufficiently confirmed, drawing on our regulatory science expertise."
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