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百健艾迪重磅MS药物Plegridy获FDA批准

来源:生物谷 2014-08-16 16:44

2014年8月16日讯 /生物谷BIOON/ --百健艾迪(Biogen Idec)8月15日宣布,FDA批准多发性硬化症药物Plegridy(聚乙二醇化干扰素β-1a),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:BIOGEN IDEC¡¯S PLEGRIDY?(PEGINTERFERON BETA-1A) APPROVED IN THE US FOR THE TREATMENT OF MULTIPLE SCLEROSIS

Friday, August 15, 2014 6:32 pm EDT

Reduces Relapses, Disability Progression and Brain Lesions with a Favorable Safety Profile ?

Only Pegylated Interferon in MS, Dosed Once Every Two Weeks ¨C

Complements Biogen Idec¡¯s Industry-Leading Portfolio of MS Products ¨C

CAMBRIDGE, Mass.Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved PLEGRIDYTM (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). PLEGRIDY, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe.

¡°PLEGRIDY offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments,¡± said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. ¡°PLEGRIDY represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.¡±

The FDA approval of PLEGRIDY is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients. ADVANCE was a two-year, Phase 3, placebo-controlled (in year one) study that evaluated the efficacy and safety of PLEGRIDY administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received PLEGRIDY for the duration of the study.

In the first year of 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 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale, by 38 percent (p=0.0383) compared to placebo. PLEGRIDY also significantly reduced the number of new gadolinium-enhancing [Gd+] lesions by 86 percent (p<0.0001) and reduced new or newly enlarging T2-hyperintense lesions by 67 percent (p<0.0001) compared to placebo.

The most common adverse reactions were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching and joint pain. The ADVANCE two-year safety data were consistent with safety results observed in year one.

¡°PLEGRIDY is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two week dosing schedule administered by an innovative delivery system,¡± said Peter Wade, M.D., medical director for neurology at the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research in Hartford, CT. ¡°As a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness.¡±

PLEGRIDY has been recently approved by the European Commission.

¡°It is always encouraging to have additional treatment options that may help people with MS manage their disease as we move towards our ultimate goal of ending MS forever,¡± said Dr. Timothy Coetzee, chief advocacy, services and research officer at the National MS Society.

For more information on PLEGRIDY, prescribing information and financial assistance programs visit PLEGRIDY.com or biogenidec.com.

About PLEGRIDY?

PLEGRIDY is a new subcutaneous injectable therapy indicated for relapsing forms of MS, 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.

Clinical and MRI data from the ADVANCE study of PLEGRIDY demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further support its clinical efficacy profile. The safety and tolerability profile of PLEGRIDY observed in ADVANCE was consistent with that of established MS interferon therapies.

The recommended dosage of PLEGRIDY is 125 micrograms injected subcutaneously every 14 days. Patients should start treatment with 63 micrograms on day one. On day 15, the dose is increased to 94 micrograms, reaching the full dose of 125 micrograms on day 29.

Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure have been reported with interferon beta. Elevations in hepatic enzymes and hepatic injury have been observed with the use of PLEGRIDY in clinical studies. Depression, suicidal ideation and suicide have been reported in patients receiving interferon beta. Seizures are also associated with the use of interferon beta. Anaphylaxis and other serious allergic reactions are rare complications of treatment with interferon beta. Injection site reactions, including injection site necrosis, can occur with the use of subcutaneous interferon beta.

Congestive heart failure, cardiomyopathy and cardiomyopathy with congestive heart failure occur in patients receiving interferon beta. Interferon beta can cause decreased peripheral blood counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia. Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper and hypothyroidism, and autoimmune hepatitis have been reported with interferon beta.

For complete PLEGRIDY prescribing information, please visit PLEGRIDY.com.

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.1 Pegylation is a well-established scientific process that has been used in other therapeutic categories.

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