Recordati's Isturisa Approved in South Korea for Cushing's Disease
Key Insights
Recordati Korea (search)'s Isturisa (osilodrostat phosphate) has been approved by the MFDS for Cushing's disease (search) treatment.
Isturisa is indicated for patients unable to undergo pituitary surgery or with insufficient post-surgical results.
The drug reduces cortisol synthesis by inhibiting 11-beta-hydroxylase (search), addressing the root cause of Cushing's.
The South Korean Ministry of Food and Drug Safety (MFDS) has granted approval to Isturisa film-coated tablets (osilodrostat phosphate), a drug imported by Recordati Korea (search), for the treatment of Cushing's disease (search). This approval marks a significant advancement for patients in South Korea suffering from this rare and debilitating condition.
Isturisa is specifically indicated for Cushing's disease (search) patients who are not candidates for pituitary surgery or who have experienced inadequate outcomes following surgical intervention. Cushing's disease is characterized by chronically elevated blood cortisol levels resulting from a pituitary adenoma. This elevation increases the risk of severe endocrine metabolic disorders, cardiovascular complications, and even mortality.
The drug functions by inhibiting 11-beta-hydroxylase (search) (CYP11B1 (search)), a crucial enzyme responsible for cortisol biosynthesis in the adrenal glands. By impeding this enzyme, Isturisa effectively reduces cortisol synthesis, addressing the underlying cause of the disease.
In October of the previous year, the MFDS designated Isturisa as the 18th product to be included in the Global Innovative Product Fast-Track Support System (GIFT). This designation facilitated an accelerated review process, enabling the drug's swift introduction into the South Korean medical landscape. The ministry has stated its commitment to expediting the review and approval of therapeutic drugs with thoroughly confirmed safety and efficacy profiles, aiming to broaden treatment options for patients.