CHMP建议批准扩大诺华MS药物Gilenya欧洲标签

关键词:诺华,多发性硬化症,Gilenya,芬戈莫德

2014年5月1日讯 /生物谷BIOON/ --诺华(Novartis)4月29日宣布,多发性硬化症药物Gilenya(fingolimod,芬戈莫德)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准扩大Gilenya用于复发缓解型多发性硬化症(RRMS)治疗的欧洲标签,将既往对至少一种疾病修饰疗法(DMT)(包括最新获批的DMTs)无响应的成人患者群体纳入该药的治疗范围。目前,Gilenya已获欧盟批准,用于对注射药物干扰素β治疗无响应的复发缓解型多发性硬化症(RRMS)患者以及病情迅速恶化的重度多发性硬化症(MS)患者的治疗。

诺华同时公布了在MS患者中开展的关键性FREEDOMS和FREEDOMS II期临床的新汇总分析,这些数据证实了Gilenya在横跨多发性硬化症(MS)4个关键衡量措施(复发率、MRI病变、脑容量损失、残疾进展)的一致性疗效。通过有效药物及疾病管理解决这4个衡量措施,对于改善MS患者的治疗过程至关重要。

新的汇总数据表明,在过去一年中经过治疗的高疾病活动度MS患者群体,Gilenya在横跨以下衡量措施取得了显著的疗效:复发率:与安慰剂相比,Gilenya使复发率(按年化复发率计算)降低48%;MRI病变:与安慰剂相比,Gilenya使新的T2病变的形成降低69%;脑容量损失:与安慰剂相比,Gilenya使脑容量损失降低46%;残疾进展:采用严格的6个月残疾衡量,与安慰剂相比,Gilenya使残疾进展降低45%。

关于Gilenya:

Gilenya(fingolimod,芬戈莫德)是一种神经鞘氨醇1-磷酸受体调节剂,是获批用于多发性硬化症(MS)治疗的首个口服疾病修饰疗法(DMT),该药于2010年获FDA批准,于2011年获欧盟批准。(生物谷Bioon.com)

英文原文:CHMP recommends EU label expansion of Novartis' Gilenya and data at AAN confirm efficacy on pre-treated MS patients

-CHMP has recognized Gilenya's favorable benefit/risk profile and recommends EU label expansion to patients not responding to DMTs beyond interferon

-AAN data: Gilenya reduces relapse rates, new MRI lesion counts, brain volume loss & disability progression in pre-treated MS patients with high disease activity

-Gilenya is the only oral DMT that is effective across four key measures of MS (relapse rates, MRI lesions, brain volume loss and disability progression)

Basel, April 29, 2014 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to expand the EU label for Gilenya? (fingolimod) in relapsing remitting multiple sclerosis (RRMS). The recommendation is to expand the label to include adult patients who have not responded to at least one disease-modifying therapy (DMT), including newly-approved oral DMTs. Gilenya is currently licensed in the EU for adult patients with RRMS who have not responded to treatment with interferons, or have rapidly evolving severe MS[1].

Novartis also announced new pooled analyses presented at the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania from the pivotal FREEDOMS and FREEDOMS II trials in multiple sclerosis (MS), confirming the consistent efficacy of Gilenya across four key measures of MS (relapse rates, MRI lesions, brain volume loss and disability progression)[2]. Addressing these four measures through effective treatment and disease management is important for improving the course of MS for patients

"We are very pleased that the CHMP has recognized the favorable benefit-risk profile of Gilenya and made a recommendation to broaden its label to allow patients who have failed on other disease-modifying therapies to be switched to Gilenya treatment," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Additionally, the new analyses at AAN confirm Gilenya's robust efficacy across four key measures of MS disease activity, which is important to give patients as much time free of functional impairment."

The pooled analyses from the FREEDOMS and FREEDOMS II trials show that in patients with high disease activity previously treated in the past year, Gilenya demonstrated significant efficacy across the following measures:

Relapses - Gilenya reduced relapses (as measured by the annualized relapse rate) by almost half (48%) compared to placebo
MRI lesions - new T2 lesion formation was reduced by 69% compared to placebo
Brain volume loss - Gilenya reduced the rate of brain volume loss by 46% compared to placebo
Disability progression - using a stringent six-month disability measure, Gilenya reduced disability progression by 45% compared to placebo[2].
About the FREEDOMS and FREEDOMS II trials
FREEDOMS and FREEDOMS II are pivotal phase 3, 2-year, placebo-controlled trials that assessed the efficacy and safety of Gilenya[3],[4]. Although the study designs were similar, patient baseline characteristics were different between FREEDOMS and FREEDOMS II, including patient age, disease duration and previous treatment history[2]-[4].

The pooled post-hoc analyses presented at AAN look at clinical and MRI outcomes in patients previously treated in the past year who had at least one relapse in the previous year and either at least one gadolinium-enhancing T1 lesion or at least 9 T2 lesions at baseline; or a patient who had equal or more relapses in the year before baseline than in the previous year[2].

The clinical and MRI outcomes were annualized relapse rate (ARR), time to 3 and 6 month confirmed disability progression, the percentage of change from baseline in brain volume (brain volume loss), the number of gadolinium-enhancing T1 lesions and the number of new/newly enlarged T2 lesions (MRI lesions)[2].

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerve and spinal cord[5]. The evolution of MS results in an increasing loss of both physical (e.g. difficulty with walking) and cognitive (e.g. problems with mental tasks or memory) function[6]. This has a substantial negative impact on the approximately 2.3 million people worldwide affected by MS[7], a disease that begins in early adulthood, most often between the ages of 20 and 40[8].

The loss of physical and cognitive function is driven by two main types of damage that both contribute to widespread loss of neurons (nerve cells in the brain and spinal cord that transmit impulses): discrete inflammatory lesions, focal damage, in the brain that can clinically manifest as relapses; and ongoing, more diffuse damage that starts early in the disease and causes the progressive loss of brain tissue, including neurons, and over time is associated with both physical and cognitive problems[9]-[11].

About Gilenya
Gilenya is the only oral disease modifying therapy (DMT) that works on four key measures of multiple sclerosis (MS) disease activity - relapses, MRI lesions, brain volume loss and disability progression[2],[3],[12]-[15].

Gilenya reduces both the distinct inflammatory lesions in the brain (focal damage) that can clinically manifest as relapses, and the ongoing, underlying damage in the brain (diffuse damage) that starts early in the disease[9]-[11],[16]-[18]. Diffuse damage often goes unnoticed, causes the loss of neurons and over time is associated with both physical and cognitive problems[9]-[11]. Gilenya's reduction of both focal damage and diffuse damage is due to its impact on the inflammatory process (peripheral action) and its ability to enter the CNS and impact from within the CNS (central action)[16]-[18]. It is by addressing both focal and diffuse damage that the course of MS can be effectively impacted, helping to preserve a patient's physical (e.g. difficulty with walking) and cognitive (e.g. problems with mental tasks or memory) function.

To date, more than 91,500 patients worldwide have been treated with Gilenya in both clinical trial and post-marketing setting[18].

(责任编辑:lishuheng)

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