Patients with idiopathic pulmonary fibrosis, a rare disease in which lung tissue scars for unknown reasons and breathing capacity steadily declines, will have a wider range of treatment options. A new drug that suppresses scarring and inflammation in lung tissue through a different mechanism from existing therapies has won approval in South Korea.
The Ministry of Food and Drug Safety said on the 15th that it had approved Jascayd (ingredient name nerandomilast), an imported orphan drug used to treat idiopathic pulmonary fibrosis.
Idiopathic pulmonary fibrosis is a condition in which chronic inflammation and scarring of unknown cause harden lung tissue, gradually reducing lung function. As the disease progresses, normal breathing becomes increasingly difficult.
Jascayd works by selectively inhibiting an enzyme known as phosphodiesterase 4, or PDE4. It reduces the expression of substances that trigger scarring and inflammation in lung tissue, producing anti-fibrotic and anti-inflammatory effects.
The ministry said it expects the drug to offer a new treatment opportunity for patients with idiopathic pulmonary fibrosis because its mechanism of action differs from that of existing therapies.
The ministry designated Jascayd as the 16th product under its Global Innovative Products on Fast Track (GIFT) program and conducted an expedited review. GIFT supports innovative medical products from the early stages of clinical development so they can reach the market more quickly.
"We will continue to review and approve treatments whose safety and effectiveness have been sufficiently confirmed, in order to expand treatment opportunities for patients," a ministry official said.