Phase III LINC-4 study of Isturisa for the treatment of patients with Cushing’s disease.- Recordati

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 on existing clinical evidence and affirms the effectiveness of isturisa in this hard-to-treat patient population. isturisa has recently received marketing authorization in the european union (january 2020) and united states (march 2020) for the treatment of cushing’s syndrome and cushing’s disease, respectively.></0.0001).>