On March 06, 2020, the U.S. Food and Drug Administration has announced the approval of new medication Isturisa (osilodrostat), the first and only cortisol synthesis inhibitor and a new non-surgical option for the treatment of patients with Cushing’s Disease (CD)—a rare disease in which patients' adrenal glands produce excessive levels of the hormone cortisol who cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. (1)
Isturisa (also known as osilodrostat) is a milestone and new non-surgical treatment originally developed by Novartis Pharmaceuticals but acquired by Recordati (an Italy-based European specialty pharmaceutical group) in June 2019 to treat Cushing's Disease. The drugmaker Recordati Rare Diseases Inc. is a public international specialty pharmaceutical company committed to the research and development of new specialties with a focus on treatments for rare diseases. Currently, Recordati has operations throughout the whole of Europe, including the United States of America, Canada, Russia, Turkey, North Africa, Mexico, some South American countries, Japan and Australia.
Recordati Rare Diseases is committed to making this innovative treatment available for all patients suffering from endogenous Cushing’s Syndrome (CS) worldwide and the European approval and subsequent launch is an important first step in this direction according to the drugmaker. (2)
Based on the National Institutes of Health (NIH) study, Cushing Disease is estimated to occur in 10 to 15 per million people worldwide. This disease usually occurs in adults between the ages of 20 and 50; however, children may also be affected. For unknown reasons, Cushing Disease affects females more often than males. (3)
