Recordati Industria Chimica & Farmaceutica SPA has been given the green light from the European Commission to market Isturisa, the Cushing's syndrome drug it acquired from Novartis AG as part of a $390m deal inked with the Swiss major in July last year.
Isturisa (osilodrostat) is a cortisol synthesis inhibitor which works by inhibiting 11-beta-hydroxylase, an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. The approval, which follows a positive opinion in November from the European Medicines Agency’s drug evaluation committee, the CHMP, was primarily based on data from the LINC-3 study