MFDS Grants Rare Drug Approval for Treatment of 'Cushingbyeong'
The Ministry of Food and Drug Safety announced on the 11th that Recordati Korea has been approved to import the rare drug 'Isturisa Film-Coated Tablets (Osilodrostat Phosphate)'.
The Ministry expects this drug to provide a new treatment opportunity for patients with Cushing's disease who are unable to undergo pituitary surgery or have insufficient effects after surgery.
Cushing's disease is a rare disorder characterized by chronic elevation of blood cortisol levels due to pituitary adenomas, etc., leading to severe endocrine metabolic disorders, cardiovascular complications, and increased risk of death. The treatment works by inhibiting 11-beta-hydroxylase (CYP11B1), which is responsible for cortisol biosynthesis in the adrenal glands, thereby reducing cortisol synthesis and producing therapeutic effects.
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The Ministry of Food and Drug Safety reported that last October, this treatment was designated as the 18th product under the 'Global Innovative Fast Track (GIFT)' system and was reviewed promptly.
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