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百健艾迪多发性硬化症药物Plegridy获欧盟批准

来源:生物谷 2014-07-26 15:32

2014年7月26日讯 /生物谷BIOON/ --百健艾迪(Biogen Idec)7月23日宣布,药物Plegridy(聚乙二醇化干扰素β-1a)获欧盟委员会(EC)批准,用于复发-缓解型多发性硬化症(RRMS)成人患者的治疗,RRMS是多发性硬化症(MS)的最常见类型。Plegridy通过注射笔(Plegridy Pen)皮下注射给药,每2周1次。Plegridy Pen是一种新的预充式即用型自动注射笔。

Plegridy是一种皮下注射剂型(subcutaneous,SC)聚乙二醇化干扰素β-1a药物,开发用于复发型多发性硬化症(RMS)的治疗。Plegridy是唯一一种获批用于复发缓解型多发性硬化症(RRMS)的聚乙二醇化干扰素,已被证明能够显著减轻疾病的活动,包括复发次数、核磁共振脑部病变及残疾进展。

Plegrid的获批,是基于全球性关键III期ADVANCE研究的数据。第一年的数据表明,与安慰剂相,每2周注射一次Plegridy,显著地减少了疾病的活动,包括复发、病情恶化、脑部损伤(brain lesions)等,在为期1年的治疗中,Plegridy表现出了良好的安全性和耐受性,达到了所有的主要终点和次要终点。第二年的数据,疗效和安全性与第一年观察到的结果一致。

近30年来,在多发性硬化症(MS)药物开发领域,百健艾迪一直处于领先地位,其强大的药物组合及在研的其他药物,能够从最早迹象的出现至病情晚期,帮助管理MS疾病。

Plegridy是一种实验性皮下注射剂型聚乙二醇化干扰素β-1a,这是一种新的分子实体,利用聚乙二醇化技术来延长干扰素β-1a的半衰期,延长其在体内的循环时间,能够减少用药次数。该药是百健艾迪数种干扰素类药物中的一员,这些药物常用于MS的一线治疗。(生物谷Bioon.com)

英文原文:PLEGRIDY™ (Peginterferon beta-1a) Approved in the European Union for the Treatment of Multiple Sclerosis

– Reduces Relapses, Disability Progression, and MRI Brain Lesions, with a Favorable Safety Profile Consistent with the Established Interferon Class –

– Initial Country Launches Expected to Begin in the Coming Weeks –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) announced that the European Commission (EC) has granted marketing authorization for PLEGRIDYTM (peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). PLEGRIDY is dosed once every two weeks and is administered subcutaneously with the PLEGRIDY PEN, a new ready-to-use autoinjector, or a prefilled syringe.

“PLEGRIDY offers people living with MS an interferon with compelling efficacy that requires considerably fewer injections than other platform therapies," said George A. Scangos, Ph.D., chief executive officer at Biogen Idec. “The approval of PLEGRIDY demonstrates our commitment to improving the lives of patients by providing innovative therapies that meet their individual needs, including flexibility in managing their disease.”

PLEGRIDY, the only pegylated interferon approved for use in RRMS, has been proven to significantly reduce important measures of disease activity, including number of relapses, MRI brain lesions, and disability progression.

The EC approval of PLEGRIDY is based on results from one of the largest pivotal studies of a beta interferon conducted, ADVANCE1, which involved more than 1,500 patients with relapsing forms of MS.

In the ADVANCE clinical trial, PLEGRIDY, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007).

PLEGRIDY reduced the risk of sustained disability progression confirmed at twelve weeks by 38 percent (p=0.0383) and at twenty four weeks by 54 percent (p=0.0069, post-hoc analysis). In addition, the number of gadolinium-enhancing [Gd+] lesions was significantly reduced by 86 percent (p<0.0001) compared to placebo.

Results over two years of ADVANCE confirm that its robust efficacy was maintained beyond the placebo-controlled first year of the study.

“The safety and efficacy that PLEGRIDY has demonstrated, combined with its less frequent dosing schedule offers MS patients an option to put their treatment in the background for longer stretches of time,” said Professor Bernd C. Kieseier, M.D., Heinrich-Heine Universität, Dusseldorf.

The safety and tolerability profile of peginterferon beta-1a observed in ADVANCE1 was consistent with that of established MS interferon therapies. The most commonly reported adverse drug reactions with peginterferon beta-1a treatment (incidence ≥10% and at least 2% more frequent on peginterferon beta-1a than on placebo) were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching, and joint pain.1

PLEGRIDY is the fifth therapy to be offered by Biogen Idec to people living with MS, expanding on a portfolio that addresses individual patient needs.

About PLEGRIDY™

PLEGRIDY is a subcutaneous injectable therapy for relapsing-remitting multiple sclerosis (RRMS), in which interferon beta-1a is pegylated to extend its half-life to permit a less frequent dosing schedule. PLEGRIDY is a member of the interferon class of treatments for MS.

According to the EU Summary of Product Characteristics (SmPC), the recommended starting dose of PLEGRIDY is 63 micrograms at dose 1, increasing to 94 micrograms at dose 2, reaching the full dose of 125 micrograms by dose 3 and continuing with the full dose (125 micrograms) every 2 weeks thereafter.

The safety and tolerability profile of PLEGRIDY observed in ADVANCE1 was consistent with that of established MS interferon therapies. PLEGRIDY should be administered with caution to patients with previous depressive disorders, seizures, severe hepatic impairment and severe renal impairment. Cytopenias, including rare severe neutropenia and thrombocytopenia, have been observed in patients treated with PLEGRIDY. The following have been reported with interferon beta medicinal products including PLEGRIDY: Elevations in hepatic enzymes, serious hypersensitivity reactions, injection site reactions with subcutaneous administration, including injection site necrosis, and worsening of cardiac disease.

In addition, the EU SmPC indicates that the use of interferon beta products is associated with cases of nephrotic syndrome, thrombotic microangiopathy manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), hyper and hypothyroidism, hepatitis, autoimmune hepatitis, rare cases of severe hepatic failure, and decreased peripheral blood counts, including rare pancytopenia.

About Pegylation

Pegylation prolongs the circulation time of the molecule in the body by increasing its size, thus enabling a longer half-life, stabilizing the molecule by improving its solubility and shielding the molecule from enzymes in the body that try to break it down into smaller particles.3 Pegylation is a well-established scientific process that has been used for more than 20 years.2,3

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord and optic nerves. Symptoms may be mild or severe, ranging from numbness in the limbs to paralysis or loss of vision. The progression, severity and specific symptoms of MS are unpredictable and vary from one person to another. MS affects more than 2.3 million people worldwide,4 with more than 600,000 sufferers in the European Union.5 Relapsing-remitting MS (RRMS) is the most common form of MS accounting for 85 percent of cases. It is characterized by clearly defined acute attacks with full recovery or with residual deficit upon recovery.6

About Biogen Idec

Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For product labeling, press releases and additional information about the Company, please visit www.biogenidec.com.

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