非格司亭Lonquex(XM22 lipegfilgrastim)

药店国别:

产地国家:韩国

处方药:

所属类别: 6毫克/注射器 1注射器/盒

包装规格: 6毫克/注射器 1注射器/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:TEVA

原产地英文商品名:Lonquex(6mg/Syringes 1Syringes)

原产地英文药品名:Lipegfilgrastim

中文参考商品译名:Lonquex(6毫克/注射器 1注射器/盒)

中文参考药品译名:长效非格司亭

曾用名:无

简介

2013年8月10日,梯瓦制药的新药Lonquex(Lipegfilgrastim)被欧盟委员会批准用于降低肿瘤患者经细胞毒化疗后嗜中性白血球减少(低白细胞计数)及发热性中性粒细胞减少的持续时间,每一化疗周期给予一次皮下注射剂量。

这使其成为安进旗下重磅产品培非格司亭的竞争对手。和培非格司亭(聚乙二醇非格司亭)一样,Lonquex是一种长效的重组粒细胞集落刺激因子(G-CSF)。安进除了长效培非格司亭之外,还有一种短效的非格司亭。

梯瓦制药已在欧洲和美国上市了非格司亭的一种生物仿制药。Lonquex完成了完整的III临床试验,结果显示Lonquex对于缩短癌症化疗后中性粒细胞减少持续时间,其安全性和有效性可与培非格司亭相媲美。

“这对梯瓦制药来说是一个重要的里程碑,也证明了我们致力于改变癌症患者生活的信念。

”梯瓦制药制的Rob Koremans这样评论说。

Lonquex是梯瓦制药品牌药物部门被批准上市的首款生物药物。这次欧盟对Lonquex的批准比预期的时间要早,Lonquex的上市申请在欧洲人用医药产品委员会(CHMP)给出积极意见后仅8周就获批了。

梯瓦制药制的生物药物研发线上还有Reslizumab,这是一款单克隆抗体药物,以白介素-5 (IL-5)为靶点,用于中至重度哮喘,该药目前处于III期临床研究阶段。还有一款名为Balugrastim的混合白蛋白G-CSF,这款药物与Lonquex类似,梯瓦制药制称其为一款“Biobetter”型药物。

英文版说明

Lonquex(lipegfilgrastim)Lonquex(lipegfilgrastim): new option for chemotherapy-induced neutropeniaTeva has launched Lonquex (lipegfilgrastim), a sustained-duration granulocyte-colony stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia.Lonquex is licensed for the reduction in duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy (except chronic myeloid leukaemia and myelodysplastic syndromes).The recommended dose for Lonquex is 6mg given by subcutaneous injection into the abdomen, upper arm or thigh approximately 24 hours after cytotoxic therapy. A single dose per chemotherapy cycle is recommended.Regular monitoring of the platelet count, haematocrit and white blood cell count is recommended during treatment with Lonquex. In patients predisposed to hypokalaemia, serum potassium should also be monitored.PHARMACOLOGYLipegfilgrastim is a glyco-pegylated G-CSF which binds to the human G-CSF receptor in the same way as filgrastim and pegfilgrastim. The decreased renal clearance of the pegylated formulation confers a sustained duration of action on lipegfilgrastim compared with filgrastim, allowing once-per-cycle administration.CLINICAL STUDIESThe efficacy and safety of lipegfilgrastim were compared with pegfilgrastim in a phase III randomised controlled study involving 202 patients with high-risk stage II, III or IV breast cancer receiving myelosuppressive chemotherapy with doxorubicin and docetaxel. Study participants, who had an ECOG performance status >2, an ANC >1.5 x 109/L and a platelet count >100 x 109/L, were randomised to receive a single 6mg subcutaneous injection of lipegfilgrastim or pegfilgrastim approximately 24 hours after chemotherapy for a maximum of four 21-day cycles.Non-inferior to pegfilgrastimThe mean duration of severe neutropenia (ANC <0.5 x 109/L) in the first cycle of chemotherapy in the per protocol study population (n=94 in both groups) was similar in both treatment groups (0.8+0.9 days in the pegfilgrastim group versus 0.7+0.9 days in the lipegfilgrastim group) demonstrating non-inferiority of lipegfilgrastim to pegfilgrastim (least squares mean difference -0.218 [95% CI -0.498%, 0.062%], p=0.126).Safety profileThe safety profile of lipegfilgrastim was found to be similar to that of pegfilgrastim. Alopecia, nausea, asthenia, neutropenia, bone pain, erythema, leucopenia and diarrhoea were the most commonly reported adverse effects, and may be attributable to myelosuppressive chemotherapy or the primary disease rather than drug treatment.

 

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