Last week the FDA approved a new ORAL therapy, Recorlev (levoketoconazole) from Xeris Biopharma Holdings, 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.
Cushing’s is a rare disease and Recorlev was granted an Orphan designation. There are fewer than 20,000 individuals with a Cushing’s diagnosis in the US and fewer with the endogenous hypercortisolemia diagnosis.
Xeris did not announce pricing for Recorlev. The therapy is a next generation version of ketoconazole (tablets), a relatively inexpensive drug but not indicated for endogenous hypercortisolemia. That being said, there are plenty of examples where the new therapy is priced well above its sister legacy formulation. Several therapies have been approved for Cushing’s in recent years and all are considered specialty therapies.
Xeris did not announce distribution details for Recorlev, however, they have launched a patient support HUB which has all the hallmarks of using the specialty pharmacy channel. Recorlev will be available later in Q1-22.