PUTEAUX, France--(BUSINESS WIRE)--Recordati Rare Diseases announce today publication of the long-term outcomes from the open-label extension period of the Phase III LINC 3 study of Isturisa® in The European Journal of Endocrinology.1 These data support the long-term utility of Isturisa® in the maintenance treatment of patients with Cushing’s disease and reinforce Isturisa as an effective and well-tolerated oral therapy. Isturisa® is indicated in the EU for the treatment of adult patients with endogenous Cushing’s syndrome,2 a rare and debilitating condition of hypercortisolism that is caused by a pituitary adenoma (Cushing’s disease).3
LEBANON, N.J.--(BUSINESS WIRE)--Recordati Rare Diseases Inc. announced today that the Phase III LINC 3 study demonstrates ISTURISA® (osilodrostat) improves physical features associated with hypercortisolism in patients with Cushing’s disease. ISTURISA is indicated in the United States for the treatment of adult patients with Cushing’s disease. These findings were presented at the American Association of Clinical Endocrinology (AACE) annual meeting by Alberto Pedroncelli MD, Head of Clinical Development & Medical Affairs, Global Endocrinology, Recordati AG.
PUTEAUX, France--(BUSINESS WIRE)--Recordati Rare Diseases announces today that Lancet Diabetes & Endocrinology has published positive results from the Phase III LINC-3 pivotal study of Isturisa®, recently approved for the treatment of endogenous Cushing’s syndrome in adults. Patients with Cushing’s disease, the most common form of endogenous Cushing’s syndrome, have an increased risk of significant comorbidities, including cardiovascular and cerebrovascular diseases as a result of excessive cortisol levels.1 Data from the large LINC-3 study, which enrolled 137 patients with Cushing’s disease, demonstrate that Isturisa® rapidly reduces mUFC and sustains this reduction alongside improvements in comorbidities, clinical signs and patients’ quality of life over 48 weeks.
PUTEAUX, France--(BUSINESS WIRE)--Recordati Rare Diseases today announces positive results from the large Phase III LINC-4 study of Isturisa® (osilodrostat) for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. Data from the LINC-4 study demonstrate that a significantly higher proportion of patients receiving Isturisa® achieve normal mUFC, the primary treatment goal for Cushing’s disease, after 12 weeks of treatment versus placebo (77% vs 8%; P<0.0001). Improvements in mUFC levels are sustained over 36 weeks of treatment (81% of patients). Isturisa® is well tolerated and has a manageable safety profile, with the most common adverse events in LINC-4 being arthralgia, decreased appetite, fatigue, and nausea. The findings from LINC-4, the first Phase III study of a medical therapy in Cushing’s disease to contain an upfront placebo-controlled phase, builds upon existing clinical evidence and affirms the effectiveness of Isturisa® in this hard-to-treat patient population.1-3
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.