FDA approves sNDA for Recordati’s Isturisa

Italian pharma major Recordati (RECI: MI) today announced that the US Food and Drug Administration (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.

The Isturisa indication expansion was supported by the Isturisa extensive clinical development program which includes over 350 patients. Recordati gained rights to the drug from Swiss pharma giant Novartis (NOVN; VX) in 2019, in a deal worth around $300 million.