Recordati Rare Diseases now holds Isturisa European MA

Recordati Rare Diseases is now the European Marketing Authorization holder of Isturisa (osilodrostat) indicated for Adult patients with Endogenous Cushing’s Syndrome  

Paris, 8 April, 2020 – Recordati Rare Diseases today announces the transfer of the European Marketing Authorization of Isturisa (osilodrostat). The transfer includes all EU member states plus the UK, Norway, Iceland and Liechtenstein.

Isturisa is authorized for the treatment of adult patients with Cushing’s syndrome. Isturisa is a potent inhibitor of 11β-­hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis¹. Isturisa has demonstrated rapid and sustained normalization of cortisol levels in a significant proportion of adult patients with a manageable safety profile, making this a novel oral treatment option for patients with Cushing's syndrome^{2, 3}

Cushing's syndrome is an endocrine disorder caused by excessive cortisol, a vital hormone that regulates metabolism, maintains cardiovascular function and helps the body respond to stress.   It is a rare but serious disease that most commonly affects adults as young as 20 to 50 years and affects women three times more often than men. It may present with weight gain, central obesity, a round, red full face, severe fatigue and weakness, striae (purple stretch marks), high blood pressure, depression and anxiety. Cushing's syndrome can cause severe illness and death with mortality up to four times higher than in the healthy population^{4, 5, 6}.

‘‘Isturisa (osilodrostat) is an important and welcome new treatment option in the management of patients with Cushing’s syndrome, a severe, potentially life-threatening rare disease,” said Rosario Pivonello, M.D., Professor at the Department of Molecular and Clinical Endocrinology and Oncology of the Frederico II University of Naples, Italy. “Cushing’s syndrome results in an increased risk of cardiovascular and cerebrovascular diseases, as well as hypercoagulability, diabetes, infections, depression, and decreased quality of life.  If not appropriately treated, Cushing’s syndrome has increased mortality. The primary treatment goal is the normalization of cortisol levels. Until now, patients have had few approved options, either with limited efficacy or with too many adverse effects. With this new oral treatment, having shown efficacy and safety in a prospective long-term setting, we have a therapeutic option that will help address patients’ needs in this underserved patient population.”