FDA Approves Expanded Use of Recordati’s ISTURISA® for Cushing’s Syndrome

Recordati Industria Chimica e Farmaceutica SPA ( (IT:REC) ) has provided an update.

Recordati announced that the FDA has approved the supplemental new drug application for ISTURISA® (osilodrostat) to treat endogenous hypercortisolemia in adults with Cushing’s syndrome who cannot undergo surgery or for whom surgery has not been successful. This approval expands the previous indication for the treatment of patients with Cushing’s disease, a subtype of Cushing’s syndrome, and is supported by a comprehensive clinical development program involving over 350 patients. The extension of ISTURISA®’s indication addresses an important unmet need and is expected to generate significant added value for Recordati, enhancing its position in the rare diseases segment.

More about Recordati Industria Chimica e Farmaceutica SPA

Recordati is an international pharmaceutical group listed on the Italian Stock Exchange, with roots dating back to a family pharmacy in Northern Italy in the 1920s. The company offers therapeutic options in specialty and general medicine, as well as rare diseases, and operates in about 150 countries across the EMEA, Americas, and APAC regions. Recordati integrates activities from clinical development to production, marketing, and licensing of chemical and finished products.

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