FDA grants Isturisa (osilodrostat) expanded indication for the treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome – Recordati

Recordati announced that the FDA has approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat),  for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. This is an expansion of the previous indication for the treatment of patients with Cushing’s disease which is a sub-type of Cushing’s syndrome. This indication expansion was supported by the  Isturisa  extensive clinical development program which includes over 350 patients.

Scott Pescatore, Executive Vice President of Rare Diseases at Recordati, commented, “We are pleased that with the label expansion for ISTURISA in the U.S. to endogenous hypercortisolemia in patients with Cushing’s syndrome, this important unmet need can now be addressed with a further treatment modality. Cushing’s syndrome can often have a devastating impact on the lives of patients and their families. Elevated cortisol levels in Cushing’s syndrome, if not properly controlled, can be associated with severe complications such as diabetes, osteoporosis, cardiovascular and increased risk of infections. We are encouraged that more patients are now able to benefit from treatment with ISTURISA and remain confident in its potential to continue creating important value for the Group, as reflected in the recently updated peak sales expectations for the product.”

Dr. Maria Fleseriu,  Professor of Medicine and Neurological surgery and director of the Pituitary Center at Oregon Health & Science University and a global PI for LINC studies added, “The expanded indication of osilodrostat is a significant advancement in the treatment of patients with Cushing’s syndrome for whom surgery is not an option or has not been curative, this therapy gives me the opportunity to normalize cortisol levels in these patients.”