欧盟委员会近日宣布,指定Maxim Pharmaceutical公司的Ceplene(二盐酸组胺)为治疗急性髓性白血病的罕见病用药。 二盐酸组胺主要用于保护需要对因噬菌细胞释放的自由基产生的影响导致的癌症产生有效应答的免疫细胞(NK细胞,具有细胞毒性作用的T细胞,NK细胞/T细胞)。该药先前已被FDA指定为治疗此种适应症的罕见病用药。 二盐酸组胺注射剂(histamine dihydrochloride,Ceplene)批准上市,是用于持续缓解和防止急性髓细胞样白血病(AML)成人患者首次缓解治疗后的复发新剂型。本品应与小剂量白介素-2联合用药。 部分中文Ceplene处方资料(仅供参考)
Ceplene® --------------------------------------------------------------- Indication Acute Myeloid Leukemia Remission Maintenance Therapy Target PopulationEU Big 5 34,000 patients DescriptionHistamine Dihydrochloride Dosage and AdministrationCeplene®: 0.5 mg, bid, sub-q Interleukin-2 (Proleukin®): 16,400 IU/kg, bid, sub-q Adverse ReactionsWell tolerated with mild flushing, headache and fatigue DescriptionCeplene® (histamine dihydrochloride), which has received marketing authorization by the European Commission, is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first remission in patients with Acute Myeloid Leukemia (AML). AML is the most common type of leukemia in adults. There are approximately 12,000 new cases of AML and 9,000 deaths caused by this cancer each year in the U.S. There are approximately 47,000 AML patients in the EU, with 16,400 new cases occurring each year. There are currently no other effective medical-based remission therapies for AML patients. AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis, and typically become free of detectable leukemia ("complete remission"). However, the majority of patients will experience a relapse of leukemia, usually within one to two years. The survival prognosis after a leukemic relapse is poor. Approximately 75-80 percent of patients who achieve their first complete remission will relapse, and the median time in remission before relapse is only 12 months with current treatments. Treatment with Ceplene® in conjunction with low dose IL-2 is designed to prevent leukemic relapses in AML patients in remission and prolong leukemia-free survival while maintaining a good quality of life for patients during treatment. In a Phase III clinical study of 320 patients, Ceplene® met its primary endpoint of increased leukemia-free survival (p <0.01) among AML patients in remission. The results of this trial were published in Blood, a leading scientific journal in hematology, (Blood; The Journal of the American Society of Hematology, volume 108, number 1, pp. 88-96, July 1, 2006). Stage of DevelopmentThe European Commission has approved Ceplene® for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia in first remission. Marketing rights have been licensed to Meda AB. In the U.S., Ceplene® is in Phase III. A pivotal trial to study Ceplene® in AML remission using overall survival as the primary endpoint is expected to commence in 2011. Ceplene® has been granted orphan drug status for the treatment of AML by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). |
急性髓性白血病治疗药-Ceplene(组胺二盐酸盐注射液)
借着英国第50届血液病学年度科学研讨会的即将召开,EpiCept计划届时顺势在英国推出Ceplene(组胺二盐酸盐)。
该药已通过欧盟批准用于急性髓性白血病(AML),以防止前期治疗病情得到缓解后再度恶化或复发。今天一月份,EpiCept与Meda公司达成了一项关于Ceplene的销售许可协议,药物在英国上市的具体工作由后者负责。
EpiCept首席执行官杰克·托利表示:“实践已证实AML患者采用Ceplene治疗后,可防止病情恶化和复发,它是目前唯一获准治疗该症的免疫调节类药物,很高兴看到它即将进入英国市场并造福于患者。我们将与Meda通力合作,为产品进一步进入德国乃至整个欧洲市场创造有利条件。”
氧自由基抑制剂Ceplene--恶性肿瘤及丙肝治疗药物。