The Ministry of Food and Drug Safety (MFDS) said Monday that it has approved Isturisa film-coated tablets (osilodrostat phosphate), an orphan drug imported by Recordati Korea.

Isturisa film-coated tablets are used to treat patients with Cushing's disease who cannot undergo pituitary surgery or have insufficient results after surgery.

Cushing's disease is a rare disorder characterized by chronically elevated blood cortisol levels caused by a pituitary adenoma, which increases the risk of severe endocrine metabolic disorders, cardiovascular complications, and death.

Isturisa film-coated tablets reduce cortisol synthesis by inhibiting 11-beta-hydroxylase (CYP11B1), the enzyme responsible for cortisol biosynthesis in the adrenal glands, reducing cortisol synthesis.

In October last year, the MFDS designated Isturisa film-coated tablets as the 18th product subject to the Global Innovative Product Fast-Track Support System (GIFT), allowing for rapid review and introduction into the domestic medical field.

“We will continue to do our best to expand treatment opportunities for patients by quickly reviewing and approving therapeutic drugs whose safety and effectiveness have been fully confirmed based on our regulatory science expertise,” the ministry said.