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首页 » 生物制药 » CHMP建议批准梯瓦Lonquex(长效G-CSF)用于化疗诱导型中性粒细胞减少症

CHMP建议批准梯瓦Lonquex(长效G-CSF)用于化疗诱导型中性粒细胞减少症

来源:生物谷 2013-06-04 04:16

2013年6月3日讯 /生物谷BIOON/ --梯瓦(Teva)1日宣布,Lonquex(XM22 lipegfilgrastim)获欧洲药品管理局(EMA)人用医药产品委员会(CHMP)积极意见。CHMP建议批准Lonquex用于正接受骨髓抑制性化疗的恶性肿瘤(除慢性髓性白血病和骨髓增生异常综合症)成人患者,以减少中性粒细胞减少症(neutrogena)的持续时间及发热性中性粒细胞减少症(febrile neutropenia)的发病率。

CHMP的积极意见为Lonquex在欧洲的获批开辟了道路,预计在未来几个月内,欧盟委员会(EC)会最终批准该药。

Lonquex是由GlycoPEGylation技术开发的一种长效重组粒细胞集落刺激因子(G-CSF),该药是一种新颖的、聚乙二醇化、糖基化的长效型非格司亭(filgrastim),作为一种每周期一次固定剂量、皮下注射型药物,用于正接受骨髓抑制性化疗的患者(除慢性髓性白血病及骨髓增生异常综合症)中性粒细胞支持。(生物谷bioon.com)

英文原文:Teva’s Lonquex?(XM22 lipegfilgrastim) Recommended for Approval in the EU for the Reduction of Chemotherapy-Induced Neutropenia (CIN)

CHMP Positive Opinion represents step forward in bringing Lonquex? to market across EuropeApproval recommendation marks major development in Teva’s drive to bring strong product pipeline to market

Teva Pharmaceutical Industries Ltd (NYSE:TEVA) announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended that a Marketing Authorization may be issued in the European Union for Lonquex? (XM22 lipegfilgrastim) for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). The CHMP positive opinion opens the way to a final approval decision from the European Commission expected within the next few months.

Lonquex? (lipegfilgrastim) is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) based on novel GlycoPEGylation technology. Lipegfilgrastim is a novel, pegylated and glycosylated long-acting form of filgrastim, intended for once-per-cycle fixed dose, subcutaneous injection for neutrophil support in patients receiving myelosuppressive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

Dr. Michael Hayden, Teva's President of Global R&D and Chief Scientific Officer, commented: “Effective prophylaxis against neutropenia and febrile neutropenia is a high priority for patients undergoing cytotoxic chemotherapy. This chemotherapy attacks rapidly dividing bone marrow cells and dramatically reduces the ability to fight off infection, which can have serious consequences for patients. Loquenex reduces the neutropenia that can lead to these consequences. We look forward to receiving final approval and being able to offer this medication to patients."

“The CHMP positive opinion is an important milestone in Teva’s efforts to provide new treatment options for patients in oncology, which is a key area of focus for Teva”, stated Dr. Rob Koremans, President and CEO of Teva Global Specialty Medicines. “We will now await the final decision from the European Commission. Teva is highly committed in delivering innovative treatments to market and its stakeholders that meet patients’ needs.”

About Chemotherapy-Induced Neutropenia (CIN)

Neutropenia is a common and potentially hazardous complication of chemotherapy treatment characterized by a decreased level of white blood cells (known as neutrophils), which can expose the patient to serious bacterial infections. This makes prophylactic treatment against neutropenia essential to avoid the significant risks associated with a compromised ability to combat such infections. CIN causes chemotherapy dose modifications, disrupting the treatment schedule causing patients to not fully benefit from chemotherapy, leading to reduced outcomes.

European clinical guidelines recommend that recombinant G-CSFs should be given on a prophylactic basis to patients with an intermediate or high risk of febrile neutropenia (FN). Pegfilgrastim is the long acting recombinant G-CSFs currently available in Europe.

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