Xeris Biopharma Holdings, Inc., a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced the U.S. Food and Drug Administration (FDA) approval of Recorlev® (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
Source:- Xeris Biopharma Holdings, Inc.
According to meta-analysis and article review Pituitary, ACTH-dependent Cushing’s syndrome is 5 to 6 times more common than Cushing’s syndrome caused by benign and malignant adrenal tumors combined. Thus, the incidence of Cushing’s disease is 25 to 31 cases per million per year. However, the reported incidence was much lower with ~1.5 to 2.5 cases per million per year. The overall incidence of CS in the United States was found to affect 6 to 7.8 cases per million population. Overall, ACTH-dependent causes account for 80 – 85% of cases, and of these 80% are due to Cushing’s disease, 20% are due to ectopic ACTH secretion and the rest are ACTH independent.
Comprehensive insight on patient segmentation based on types (ACTH-dependent Cushing’s syndrome and ACTH-independent Cushing’s syndrome), Risk factors, Clinical manifestations (Physical, Hor-monal and Metabolic/Cardiovascular) has been provided into the epidemiology (Incidence and Prevalence) section of the Cushing’s syndrome and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China.
In terms of pharmacologic therapies, Several drug candidates are in Phase II and II/ III stages of development by various companies. Key assets among these are, Recorlev from Strongbridge Biopharma, Relacorilant from Corcept Therapeutics Inc., Mifedren from HRA Pharma, Nevanimibe from Millendo Therapeutics. Among these key assets, some of the assets are being designated as orphan drug designation. The launch of key assets will positively impact the overall market in 8 MM countries. companies like Cyclacel Pharmaceuticals, Sosei Co., Ltd, Crinetics Pharmaceuticals, Inc., XOMA Corporation, Amryt Pharma plc, Ipsen SA, Orphagen Pharmaceuticals have their product in the early stage of development.
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