Gilenya® (Fingolimod) Dispenses First Prescription in China, Empowering Multiple Sclerosis Patients to Reclaim a Dynamic Life
Novartis
Drug Development and Manufacturing
Shanghai, January 7, 2020 /PRNewswire/ -- On January 6, Novartis' innovative multiple sclerosis drug Mayzent®(Fingolimod) has been prescribed for the first time in China. Following its approval on July 12, 2019, for the treatment of relapsing forms of multiple sclerosis (RMS) in patients aged 10 years and older, Gilenya®The first batch of drugs has been fully implemented in 10 hospitals across six cities, including Beijing, Shanghai, Guangzhou, Chengdu, Chongqing, and Hangzhou, marking thisThe world's first, also isCurrently the only oneOral Disease-Modifying Therapies (DMTs) for Multiple Sclerosis Covering Patients Aged 10 and Above Officially Launch in China, Benefiting Over 30,000 Patients[I], helping them regain a high-quality, vibrant life.
Ms. Zhang Ying, President of Novartis Pharmaceuticals (China), stated, “We are proud to bring Jie Lingya®Introducing to China, bringing more superior DMT treatment options for multiple sclerosis patients in China. Jielingya®“The rapid availability of these benefits to patients in China is attributable to the government’s determination and decisive action in accelerating the introduction of innovative medicines. Novartis boasts a robust pipeline of follow-on products in the field of multiple sclerosis (MS) treatment, and we are committed to bringing more innovative products and therapeutic options to patients in China. Meanwhile, we will continue to collaborate closely with the government, hospitals, patients, and industry partners, with the aim of enabling more Chinese patients with MS to benefit earlier from globally leading innovative therapies.”
The diagnosis and treatment of multiple sclerosis remain far from optimistic, with nearly 90% of patients yet to receiveDMT
Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system. It predominantly affects young and middle-aged adults aged 20–40 years, with a higher incidence in women. MS can lead to symptoms such as visual impairment, diplopia, sensory disturbances in the limbs, motor dysfunction, ataxia, and bladder or bowel dysfunction. In China, multiple sclerosis is classified as a rare disease and was included in the First Batch of the Rare Disease Catalogue in May 2018. Currently, more than 30,000 patients in China are affected by this condition.[I]。
Professor Hu Xueqiang, Chair of the Neuroimmunology Branch of the Chinese Society of Immunology and from the Department of Neurology at the Third Affiliated Hospital of Sun Yat-sen University, stated, “Patients with multiple sclerosis often live with the disease for decades, which affects their careers, partner selection, and childbearing, severely impacting their quality of life. Due to the diverse clinical manifestations in most patients with multiple sclerosis, it takes 1–5 years to confirm the diagnosis in approximately two-thirds of patients, and more than 6 years in 12% of patients. Currently, fewer than 10% of patients receive disease-modifying therapy.”[I]It can be said that the current state of diagnosis and treatment of multiple sclerosis in China is worrying.”
It is reported that multiple sclerosis is classified into multiple clinical subtypes, among which over 80%[I]Patients with relapsing-remitting multiple sclerosis (RRMS) experience a clinical course characterized by distinct relapses and remissions. Disease-modifying therapies (DMTs) are recommended as the standard treatment during the remission phase in both domestic and international guidelines and consensus statements. DMTs can effectively control the frequency and severity of relapses and delay disability progression. However, the utilization of DMTs in China remains suboptimal. Compared to the high usage rate of 86% in Europe and the United States, the usage rate of DMTs in China is only 10%.[I]。
Professor Dong Qiang, Director of the Department of Neurology at Huashan Hospital Affiliated to Fudan University, stated, “At the current stage, multiple sclerosis cannot be cured, and patients require long-term treatment. As a first-line therapy for the remission phase, disease-modifying therapies (DMTs) can help patients effectively reduce disease relapses and control disease progression by modulating immune-inflammatory responses. China’s First Batch of Rare Diseases Catalog has accelerated the approval and market entry of a number of drugs, including fingolimod, a treatment for multiple sclerosis approved in July 2019. We look forward to the introduction of more foreign products into China, thereby providing more options for treatment regimens.”
Unique Mechanism Reshapes the Treatment Landscape, Patients in Six Regions Benefit First
Jie Ling Ya®Possesses a unique dual mechanism of immunomodulation and central nervous system protection[ii], significantly improving long-term patient outcomes and holding promise for achieving the fourfold goals of multiple sclerosis treatment[iii], including “no relapses, no magnetic resonance imaging (MRI) lesions, no brain atrophy, and no disability progression”[iv]。
In multiple pivotal studies and real-world studies, Jie Lingya®All demonstrated superior efficacy[v-vii], in the TRANSFORMS study involving 1,292 patients with a head-to-head comparison against interferon, Gilenya®It can significantly prolong the time to first recurrence after medication; until the 12th month of the study, 82.6% of the subjects remained free of recurrence.[vi]. Another study, the PARADIGMS trial, which included 214 subjects aged 10–17 years, showed that taking Gilenya®, 85.7% of the enrolled patients remained free of disease recurrence at 24 months post-treatment[vii]。
To benefit patients as early as possible, Jie Lingya®Following approval, the company will accelerate its nationwide deployment across hospitals in major cities throughout China. Professor Xu Xianhao, a renowned expert in the Department of Neurology at Beijing Hospital, stated, “In China, the diagnosis and treatment of multiple sclerosis (MS) have long been constrained by a lack of therapeutic options, leaving the substantial treatment needs of a large patient population inadequately met. Over the past two years, the Chinese government has placed significant emphasis on the field of rare diseases, successively releasing the First Batch of Rare Diseases Catalogue, approving the establishment of the Chinese Alliance for Rare Diseases, and fully supporting the accelerated market entry of rare disease medications, thereby consistently delivering tangible benefits to patients through concrete actions. We are delighted to see the accelerated introduction into China of globally leading disease-modifying therapies (DMTs) for multiple sclerosis. This development is poised not only to reshape the overall treatment strategy for MS in China but also to significantly improve patients’ quality of life, enabling them to regain mobility and embrace a renewed life.”
About Jie Lingya®(Fingolimod)
Jie Lingya®(Fingolimod) was included in the first batch of the "List of Overseas New Drugs for Urgent Clinical Needs" by the Center for Drug Evaluation of the National Medical Products Administration in 2018.[viii], and was officially approved in China on July 12, 2019, for the treatment of relapsing multiple sclerosis (RMS) in patients aged 10 years and older. Gilenya®(Fingolimod) is the first and currently the only first-line disease-modifying therapy (DMT) approved for patients aged 10 years and older.[ix]. To date, Jielingya®Approved in over 80 countries worldwide, benefiting nearly 300,000 patients[x]. Meanwhile, Jie Lingya®(Fingolimod) Safety and tolerability have been extensively validated in clinical trials and real-world settings over a period of up to 15 years.[xi], Jielingya®(Fingolimod) Its unique mechanisms of immunomodulation and central nervous system protection have made it a trusted treatment option for many physicians and patients.
To learn more about Jie Lingya®(Fingolimod) Product Information and Safety Data, please clickhttps://www.novartis.com.cn/jie-ling-ya-%28yan-suan-fen-ge-mo-de-xiao-nang-%29jian-duan-chu-fang-xin-xiObtain prescription information.
[i] Chinese Society of Neurology, Chinese Medical Association. (2018). Survival Report for Patients with Multiple Sclerosis in China
[ii] Chaudhry BZ, Cohen JA, Conway DS. Sphingosine 1-Phosphate Receptor Modulators for the Treatment of Multiple Sclerosis. Neurotherapeutics. 2017 Oct;14(4):859-873.
[iii] De Stefano N et al. Effect of Fingolimod on Brain Volume Loss in Patients with Multiple Sclerosis. CNS Drugs. 2017; 31(4): 289-305.
[iv] Giovannoni G et al. "No evident disease activity": The use of combined assessments in the management of patients with multiple sclerosis. Mult Scler. 2017. Doi 10.1177/1352458517703193.
[v] Kalincik T, Havrdova K, Horakova D, et al. Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis. J Neurol Neurosurg Psychiatry 2019;90:458-468.
[vi] Khatri B et al. Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS study. Lancet Neurol. 2011; 10(6): 520-529.
[vii] Chritnis T, Arnold D, Banwell B et al. Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis. N Engl J Med 2018;379:1017-27.
[viii] Notice on the Release of the First Batch of Overseas New Drugs Urgently Needed for Clinical Use, Retrieved November 1, 2018, fromhttp://www.cde.org.cn/news.do?method=viewInfoCommon&id=313990
[x] Data on file. GILENYA exposure: August 2019 cutoff. Novartis Pharmaceuticals Corp
[xi] Cohen JA1, Tenenbaum N2, Bhatt A3 Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324.