European Commission approves Roche Hemlizumab for use in adults and children with severe type A haemophilia

recently, SwissPharmaceutical(http://giant Roche announced that the European Commission (EC) has approved Hemlibra as a conventional preventive treatmentdrug(http://for severe type A haemophilia (congenital factor VIII deficiency, FVIII) in adults and children who do not produce coagulation factor VIII inhibitors in the body, preventing or reducing the frequency of bleeding eventsin addition, EC has approved Hemlibra's multiple drug regimens (once a week, every 2 weeks, every 4 weeks, subcutaneous injections) for all patients with type A haemophiliacs, including those with coagulation factor VIII inhibitors in the bodyIn the United States and the European Union, Hemlibra was approved in November 2017 and February 2018 as a routine preventive drug for patients with type A haemophilia type A who have produced coagulation factor VIII inhibitors in the body, reducing the incidence of bleeding eventsOctober 2018, Hemlibra was approved by the U.SFDA(http://as a routine preventive treatment for patients with type A haemophilia type A who do not produce coagulation factor VIII inhibitors in the body to prevent or reduce the frequency of bleeding eventsabout Hemlibra
Hemlibra is a bispecific monoclonal antibody that can activate the natural coagulation cascade reaction and restore the natural clotting process of the two proteins - the coagulation factorioni IXa and X together to restore the clotting process in patients with type A haemophilia In clinical studies, Hemlibra has been shown to significantly reduce bleeding events and improve machine function 　　Hemlibra is developed by Chinese and foreign pharmaceutical companies, and is currently developed by Sino-foreign pharmaceuticals, Roche and its gene Tektronix The drug was developed to help overcome the current clinical challenges faced by the hemophilia Type A population: the short duration of existing drug efficacy, the generation of VIII inhibitors, and the frequent demand for intravenous infusion 　　Hemlibra has been studied in one of the largest critical clinical studies to date, including four critical Phase III HAVEN studies (HAVEN-1, -2, -3, -4) This approval for extended indications in the European Union is based on data from two Phase III clinical studies (HAVEN-3 and HAVEN-4) 　　THE HAVEN-3 STUDY IS A RANDOMIZED, MULTICENTER, OPEN LABEL PHASE III STUDY CONDUCTED IN ADOLESCENTS 12 YEARS AND OLDER AND ADULTS WITH NO FACTOR VIII INHIBITORS IN THE BODY studies show edhemodore events in patients who received preventive treatment once a week and every 2 weeks significantly decreased by 96% (p.0001) and 97% (p.0001) compared to patients who did not receive preventive treatment Importantly, in another patient group in the study, patients who had previously received factor VIII prophylactic treatment in a non-interventional study switched to Hemlibra preventive therapy, allowing for patient in-patient (intra-patient, i.e., the same patient) to compare two preventive programs Based on intra-patient comparisons, Hemlibra significantly reduced bleeding events by 68% (p0.0001), making Hemlibra the first drug to show superior efficacy compared to the previous factor VIII preventive standard care drug In terms of safety, no unintended or serious adverse events associated with Hemlibra were found in the study, and common adverse events were consistent with previous studies 　　The HAVEN-4 study is a single-group, multi-center, open label Phase III study that assesses the efficacy, safety, and pharmacokinetics (PK) of subcutaneous injections of Hemlibra every 4 weeks The study enrolled 48 patients with type A haemophiliacs (12 years and older) who had or did not produce factor VIII inhibitors in the body, who had previously received on-demand or preventive treatment from factor VIII or bypass drugs The study was divided into two parts: the PK import period and the extended queue All patients entering the PK import period receiveon on-demand treatment prior to the PK introduction period (n-7), who received a single dose of 6 mg/kg subcutaneous injection Ofebra for 4 weeks and 6 mg/kg treatment every 4 weeks for at least 24 weeks to fully describe the PK characteristics In the extended cohort (n-41), patients who had an VIII inhibitor in the body (n?5) and those who did not produce an VIII inhibitor (n-36) received 3 mg/kg/week treatment for 4 weeks, followed by 6 mg/kg treatment every 4 weeks for at least 24 weeks According to the study, intermittent treatment (episodic treatment) for breakthrough bleeding (episodic treatment) is allowed based on the patient's factor VIII inhibitor status with factor VIII therapy or bypass drugs results showed that patients who had or did not produce factor VIII inhibitors received Hemlibra prophylactic treatment every 4 weeks, with 56.1% experiencing zero bleeding and 90.2% experiencing three or fewer treatments for bleeding