New drug for Cushing's syndrome! Isturia (osilodostat), a cortisol synthesis inhibitor of recordati, has been approved by the European Union!

January 16, 2020 / BIOON / -- the Italian pharmaceutical company recordati recently announced that the European Commission (EC) has approved the marketing license of the orphan drug product isturia ® (osilodostat), which is used to treat adult endogenous Cushing's syndrome (CS) The active pharmaceutical component of isturia ® is osilodostat, an inhibitor of cortisol synthesis that works by inhibiting 11 - β - hydroxylase, which is responsible for the last step in adrenal cortisol biosynthesis Isturia ® will provide 1mg, 5mg, 10mg film coated tablets The advantage of isturia ® is that it can control or normalize the cortisol level of adult CS patients, and has manageable safety, making the product a valuable treatment option for CS patients According to the data from the whole clinical project, Oslo drostat can normalize the cortisol level of most patients and improve the clinical characteristics and quality of life of the disease, so as to provide significant clinical benefits in areas where medical needs are not met In particular, in the linc-3 study, at the end of the 8-week randomized withdrawal period (week 34), the proportion of patients with normal mufc in the Oslo drostat group was significantly higher than that in the placebo group (86.1% vs 29.4%) Cortisol level control is the primary goal of CS patients EC's decision also confirms isturia's orphan drug status, which provides 10 years of market monopoly Recordati recently acquired the global rights of isturisa ® (osilodostat) from Novartis Andrea recordati, chief executive of recordati, said: "we are very pleased with the approval of isturisa ® by the European Commission The European approval and subsequent launch of recordati rare diseases, a rare diseases company of recordati group, is an important first step in this direction Symptoms of CS Cushing's syndrome (image source: omicsonline ORG) According to Baidu Encyclopedia, Cushing's syndrome (CS) is also called hypercortisolism In the past, it was also called Cushing's syndrome It is a series of clinical manifestations caused by the long-term secretion of excessive glucocorticoids (mainly cortisol) by the adrenal cortex caused by various causes of the body It is also called endogenous Cushing's syndrome The incidence rate of high incidence is 20~40 years old, the ratio of male to female is about 1:3 According to its etiology, it can be divided into ACTH dependent type and non dependent type The main manifestations are full moon face, multi blood appearance, centripetal obesity, acne, purple lines, hypertension, secondary diabetes and osteoporosis In addition, long-term use of high-dose glucocorticoids or long-term alcoholism can also cause clinical manifestations similar to Cushing's syndrome, which is called exogenous, drug-induced or Cushing like syndrome Original source: recordi: isturisa ® (osiilodrostat) approved