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百特HyQvia获欧盟委员会批准

来源:生物谷 2013-05-21 22:53

2013年5月21日讯 /生物谷BIOON/ --百特(Baxter)和Halozyme制药今天宣布,欧盟委员会(EC)已授予了HyQvia在所有欧盟成员国的上市许可(MA),作为一种替代疗法,用于原发性免疫缺陷综合征(primary immunodeficiency syndromes)及伴有继发性低丙种球蛋白血症和反复感染的骨髓瘤或慢性淋巴细胞白血病成人患者(≥18岁)的治疗。

百特称,在2013年期间将在选定的一些国家推出HyQvia,同时计划于2014年在其他欧盟国家上市销售。

HyQvia由人正常免疫球蛋白(IGSC,10%)和重组人透明质酸酶(hyaluronidase)组成,透明质酸酶有利于IGSC的分散和吸收。

HyQvia 上市许可申请(MAA)的获批,是基于一项前瞻性、开放标签、非对照、多中心III期临床试验的数据。该研究评价了HyQvia用于预防急性严重细菌感染的安全性和有效性,同时与静脉给药型免疫球蛋白的药代动力学参数进行了比较。该项研究的目的是在单一的皮下注射位点注入一剂3或4周剂量的HyQvia。

该项研究中,急性严重细菌感染率为0.025/人/年,低于所要求的疗效阈值1.0/人/年。对HyQvia的耐受性评估数据表明,最常见的不良反应为输注部位反应、头痛、疲劳、发热。(生物谷bioon.com)

英文原文:Baxter Receives Marketing Authorization for HyQvia in European Union 

BRUSSELS, BELGIUM, May 21, 2013 - Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the European Commission has granted Baxter marketing authorization in all European Union (EU) Member States for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.

"HyQvia offers patients with primary and secondary immunodeficiencies the ability to administer their treatment in a single subcutaneous site every three to four weeks. This represents an important advance for patients who are managing a chronic disease as HyQvia combines  key benefits of intravenous and subcutaneous administration into one product," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. "We look forward to introducing HyQvia in the coming weeks to support physicians and adult immunodeficient patients in Europe."

Baxter will introduce HyQvia in select countries during 2013 and plans to expand the launch to other EU countries in 2014.

"We are delighted that these patients who depend on immunoglobulin replacement treatment will have access to HyQvia," said Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics.

The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC.  The application was based on results from a phase III, prospective, open-label, non-controlled multi-center clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of the study was to infuse a 3-or 4-week dose of the treatment in a single subcutaneous site.

The rate of validated acute serious bacterial infections in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions).

About HyQvia

HyQvia is a product consisting of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The two components are packaged together as a dual vial unit: IGSC provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IGSC, increasing the bioavailability. The IGSC is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies.

HyQvia is indicated as replacement therapy in adults (> 18 years) in primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Important Risk Information

HyQvia should not be used by patients with a hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. HyQvia should not be used by patients with a systemic hypersensitivity to hyaluronidase or recombinant human hyaluronidase. HyQvia should not be used by patients with a hypersensitivity to any of the excipients, including glycine.

HyQvia must not be given intravenously.

HyQvia should not be used by women who are pregnant, or are planning to become pregnant, or are breast-feeding.

Patients should be closely monitored and carefully observed for any adverse reactions throughout the infusion period, particularly patients starting with HyQvia treatment. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the adverse reaction. In case of shock, standard medical treatment for shock should be implemented.

Thromboembolic events (e.g. myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism), renal dysfunction/failure, aseptic meningitis syndrome, and hemolysis have been observed with IG 10% administered intravenously and cannot be excluded with use of HyQvia. Thrombotic events and haemolysis have also been reported in association with the subcutaneous administration of immunoglobulin products.

Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma and may carry a risk of transmitting infectious agents.

About Immunodeficiency Disorders

Primary Immunodeficiencies (PI) are a group of more than 175 disorders in which part of the body's immune system is missing or does not function properly. Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, they are more likely to become infected and may take longer to recover from infections. When a defect in the immune system is inherited, it is called primary, or inherited, immune deficiency. It is estimated that as many as six million children and adults are affected by PI worldwide.

Secondary immunodeficiencies develop as a result of a variety of conditions such as malignancies, particularly those of the haematopoietic and lymphoreticular systems, metabolic disease and/or malnutrition. Furthermore, burns or severe infection can also cause defective immune function and poor antibody response. In particular, immunoglobulin therapies are used to treat hypogammaglobulinaemia associated with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). These patients may benefit from immunoglobulin replacement treatment in addition to standard treatment of their primary disease.

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