Shots:

• The approval is based on a study assessing Isturisa {starting dose of 2mg (bid) that could be increased q2w up to 30mg (bid)} in 137 adults with Cushing’s disease who either had undergone pituitary surgery that did not cure the disease or were not surgical candidates
• The study resulted that half of the patients had cortisol levels within normal limits @24wks. Following the above study- 71 patients entered into 8wks. study assessing Isturisa vs PBO which resulted in maintenance of cortisol level (86% vs 30%)
• Isturisa is the first FDA-approved therapy targeting the cortisol overproduction by blocking the enzyme k/a 11-beta-hydroxylase and preventing cortisol synthesis and has received FDA’s ODD for the same indication

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Ref: FDA | Image: Novartis