诺华（Novartis）6月9日宣布，欧盟委员会（EC）已批准扩大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。此前，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。
此次Gilenya扩大标签的获批，是基于自2011年3月首次获批后3年来的上市后（post-marketing）临床试验的长期疗效和安全性数据。目前，Gilenya已获80个国家批准，据估计，在临床试验及上市后试验中，有超过9.15万例患者接受了Gilenya的治疗。
今年5月，诺华公布了在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。
英文原文：
European Commission approves wider use of Gilenya (fingolimod), the first once-daily pill for multiple sclerosis
Indication expansion means clinicians will now have the flexibility to switch patients not responding to an adequate course of at least one disease modifying treatment (DMT) to fingolimod as soon as considered appropriate
Indication expansion consolidates favourable benefit/risk profile of once-daily pill fingolimod
Frimley, 9 June 2014 – Novartis is delighted to announce that the European Commission has endorsed the Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the expanded use of Gilenya® (fingolimod) for adult patients with highly active relapsing-remitting multiple sclerosis (RRMS).1
The indication expansion will now give clinicians the flexibility to use fingolimod in the highly active RRMS group, for patients needing to switch from interferons as well as glatiramer acetate and other DMTs.1
Prior to the indication expansion, fingolimod was limited for use in those patients with highly active RRMS not responding to an interferon.2
The European Commission approval was based on a favourable review of the long-term efficacy and safety data for fingolimod and comes three years after the initial licence was granted in March 2011.3 Fingolimod is now approved in 80 countries and it is estimated that more than 91,500 patients have been treated with fingolimod in clinical trials and in the post-marketing setting.4
Fingolimod is the only established oral therapy approved by NICE for the treatment of highly active RRMS that is effective across four key measures of MS disease activity – relapses, MRI lesions, brain volume loss and disability progression.5,6
Novartis will work with the relevant funding bodies to ensure that patients who meet these new criteria are able to access fingolimod in the near future.
Notes to editors
Fingolimod is a once-daily oral therapy indicated for appropriate people with highly active RRMS2
To date, more than 91,500 patients have been treated with fingolimod in clinical trials and in the post-marketing setting4
Fingolimod has been approved in 80 countries.4
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world.
