Recordati's Isturisa Approved For Cushing's In EU

Italian Firm On The Rise In Rare Diseases

Acquired from Novartis last year, Isturisa is forecast to have peak sales of over $100m. Now all eyes will be on a PDUFA date in March.

Italian flags
Flags out for Isturisa approval • Source: Shutterstock

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

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