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according to the official website of the state drug administration, recordati group's wholly-owned subsidiary in china, recordati (beijing) pharmaceutical co., ltd.,^®(ozosin phosphate tablets) have been approved for marketing by the china national medical products administration (nmpa) on september 19, 2024, for the treatment of cushing's syndrome [hypercortisolism] in adults. china's first new oral drug for the treatment of cushing's syndrome in adults has been approved, filling the gap in domestic drug treatment for this disease.

cushing's syndrome is difficult to diagnose and even more difficult to treat

cushing's syndrome is a group of syndromes caused by long-term excessive secretion of cortisol by the adrenal cortex due to various causes, also known as endogenous cushing's syndrome. hypercortisolemia acts on target organs, causing complications such as central obesity, hypertension, abnormal glucose metabolism, hypokalemia and osteoporosis.

if left untreated, cushing's syndrome will increase the burden of the disease, and studies have shown that the risk of death increases by 3-5 times. in addition, although the complications of multiple organs of the disease can be improved after treatment, some will persist, seriously affecting the quality of life of patients.

the treatment goal of cushing's syndrome is to treat the primary disease, normalize cortisol levels, relieve the patient's physical signs and clinical symptoms, treat complications of related systems, and improve the quality of life. surgical treatment has a good therapeutic effect on pituitary adenomas and ectopic tumors that secrete acth, but surgery has some complications, and some patients will relapse after surgery. therefore, drug treatment is also a very important means.

shi ruisa^®, opening a new era of drug treatment

the approved^®ozokstat (ozokstat phosphate tablets) is a potent, reversible oral inhibitor of 11β-hydroxylase, which catalyzes the final step in cortisol synthesis in the adrenal cortex. the efficacy and safety of ozokstat phosphate in adult patients with endogenous cushing's disease were evaluated in two phase iii multicenter studies (linc3 and linc4).

linc3 is a phase iii, international multicenter, double-blind, randomized discontinuation study. after a 24-week open-label single-arm treatment period, 137 patients entered an 8-week double-blind randomized discontinuation period (weeks 26-34) for patients whose average 24-h ufc level was within the upper limit of normal values ​​at week 24 and whose drug dose was not increased after week 12. at the end of the randomized withdrawal period at week 34, 86.1% of patients in the ozokrestat phosphate group maintained normal cortisol levels in ufc, and the study achieved the primary efficacy endpoint. the proportion of patients in the ozokrestat phosphate group who maintained normal mufc was significantly higher than that in the placebo group (p < 0.001).

linc4 is another global, multicenter, randomized, double-blind, placebo-controlled phase iii study, which is a randomized double-blind phase (12 weeks) and a subsequent open-label phase to compare the effectiveness of ozokrestat phosphate with placebo in patients with cushing's disease. the results showed that after 12 weeks of treatment, the proportion of patients with normalized ufc in the ozokrestat phosphate group (77.1%) was significantly higher than that in the placebo group (8%). after 12 weeks, all patients received ozokrestat phosphate until week 48, and the total remission rate at week 48 was 79.5%.

shi ruisa^® it can not only quickly reduce the average urinary free cortisol and maintain normal levels for a long time, but also improve complications and have good overall tolerance, and adverse reactions are controllable and manageable. coupled with the convenience of oral medication, it can improve the patient's quality of life while controlling cortisol levels. it is undoubtedly an ideal choice for adult patients with cushing's syndrome who cannot tolerate surgery, relapse after surgery, or are not relieved by surgery.

it is understood that shi ruisa^®(ozosin phosphate tablets) was approved in the european union in 2020 for the treatment of endogenous cushing's syndrome in adults, and was subsequently launched in 37 countries and regions including the united states and japan. today, as the first cortisol synthesis inhibitor for the treatment of adult cushing's syndrome in china, cialis^®the approval of the drug for marketing will meet the medication needs of domestic patients with cushing's syndrome, break the dilemma of no available drugs, and better serve domestic patients.

in this regard, professor liao zhihong from the department of endocrinology of the first affiliated hospital of sun yat-sen university believes that many patients with cushing's syndrome require drug treatment in addition to surgery. currently, there is almost no effective drug treatment for increased cortisol in my country. the approval and use of ozokrestat phosphate tablets will definitely bring good therapeutic effects to many patients with cushing's syndrome, promote the development and progress of this field, and encourage everyone to work together to do a better job in the field of cushing's syndrome.

professor yu yerong from the department of endocrinology and metabolism at west china hospital of sichuan university also said: in the clinical trials we participated in, we observed that ozokrestat can quickly control the patient's cortisol level and maintain the cortisol level in the normal range for a long time. at the same time, the patient's quality of life is improved. the launch of ozokrestat phosphate tablets is not only the launch of a drug, but also provides the possibility for patients to have a good life status and quality. ozokrestat phosphate tablets will bring good news to the majority of cushing's syndrome patients, giving them more choices and confidence in the treatment process.