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Recordati's Isturisa wins EU nod to treat rare hormonal disorder

Recordati Industria Chimica e Farmaceutica SpA's experimental drug Isturisa, or osilodrostat, has been approved by the European Commission to treat a rare hormonal disorder called Cushing's syndrome.

Isturisa was previously backed by a European Medicines Agency committee to treat the disorder, a severe endocrine disease caused by an enlargement in the pituitary gland that results in overproduction of the body's main stress hormone called cortisol.

The Italian pharmaceutical company, which acquired worldwide rights to Isturisa through a $390 million deal with Novartis AG in October 2019, will get 10 years of market exclusivity with orphan-drug status that was granted with the EU approval.

The agency's approval is based on a study called Linc-3, which showed that Isturisa was better than placebo in controlling cortisol levels in patients with Cushing's syndrome, meeting the trial's primary goal.