Korea approves rare-disease drug Zascaid for idiopathic pulmonary fibrosis

South Korea's food and drug safety ministry said it has approved Zascaid, an imported rare-disease medicine for idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis is a disease of unknown cause in which chronic inflammatory cells invade the alveolar walls, altering lung tissue structure and gradually reducing lung function.

Zascaid works differently from existing therapies. It selectively inhibits phosphodiesterase 4, an enzyme that breaks down and inactivates cyclic adenosine monophosphate, reducing the expression of fibrosis-inducing growth factors and inflammation-related substances that are overproduced in fibrotic lung disease. The result is an anti-fibrotic and anti-inflammatory effect, the ministry said.

The drug was designated the 16th entrant to the ministry's Global Innovative product on Fast Track, or GIFT, programme, and was reviewed under that fast-track route, the ministry said. It expects the medicine to offer a new treatment opportunity for patients through a mechanism distinct from existing therapies.

"We will continue to review and approve treatments whose safety and efficacy have been sufficiently verified, based on regulatory science expertise, so that patients' access to treatment can be expanded," the ministry said.