Recordati Rare Diseases announced that it has officially acquired marketing rights in Europe for the Cushing’s treatment Isturisa (osilodrostat), enabling the company to distribute it throughout the European Union, as well as in the U.K., Norway, Liechtenstein, and Iceland.
Isturisa, initially developed by Novartis and acquired by Recordati in 2019, is an oral treatment designed to block an enzyme called 11β-hydroxylase, which is involved in the final step of the body’s natural cortisol synthesis process. The treatment works to manage cortisol levels in Cushing’s, an endocrine disorder caused by high levels of this hormone.
Its efficacy and safety was investigated in a Phase 3 clinical trial (NCT02180217), called LINC-3, which enrolled 137 patients with the disorder.
The trial included a 24-week period where all patients received Isturisa, followed by an eight-week period where they were randomized to continue with the treatment or switch to a placebo. Patients could then choose to continue taking Isturisa for another 12 weeks.
Trial results showed that, at the end of the 34-week period, 86% of Isturisa-treated patients had normal urinary cortisol levels compared to 29% of those who were moved to placebo.
Side effects reported in more than 20% of patients and associated with Isturisa’s use included low cortisol levels, fatigue, nausea, headache, and swelling. But overall, the treatment was considered to be safe and well-tolerated.
Based on trial findings, the European Commission approved Isturisa in early 2020 for endogenous Cushing’s syndrome, where excess cortisol is due to overproduction in the body.
“Isturisa (osilodrostat) is an important and welcome new treatment option in the management of patients with Cushing’s syndrome,” said Rosario Pivonello, MD, a professor at Frederico II University, in Naples. “Until now, patients have had few approved options, either with limited efficacy or with too many adverse effects. With this new oral treatment … we have a therapeutic option that will help address patients’ needs in this underserved patient population.”
The U.S. Food and Drug Administration (FDA) approved Isturisa to treat Cushing’s disease patients for whom pituitary gland surgery is not an option or whose disease has returned after the surgery in March. In Cushing’s disease, a subtype of the syndrome, high cortisol levels are due to a tumor in the pituitary gland.
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