Adbry Approved for Atopic Dermatitis
December 28, 2021First Generic for Cuvposa Launches
January 4, 2022December 30, 2021 – The U.S. FDA has approved Recorlev® (levoketoconazole), manufactured by Xeris Biopharma, to treat endogenous hypercortisolemia in adults diagnosed with Cushing’s syndrome for whom surgery is not an option or has not been curative.
- In most cases, Cushing’s syndrome is caused by noncancerous tumors on the pituitary gland that cause prolonged heightened cortisol levels (hypercortisolemia) in the body. This can lead to multiple problems such as weakness, fatigue, bone loss, and cognitive difficulties.
- The recommended initial dosing is 150mg taken by mouth twice daily. Dosing can then be titrated up to a maximum recommended dose of 600mg twice daily, based on response to treatment.
- Xeris has launched Recorlev at a wholesale acquisition cost (WAC) $13,500 per 50 tablets.