Novartis' Innovative Migraine Prevention Drug Erenumab Launches in the Guangdong-Hong Kong-Macao Greater Bay Area

GuangzhouJuly 15, 2022PR Newswire -- Today, Novartis' innovative drug Erenumab, used for the preventive treatment of migraine, completed its first injection at Guangzhou United Family Hospital. The first batch of approvals for use in the Greater Bay Area also includes the University of Hong Kong Shenzhen Hospital and Zhongshan Chen Xinghai Hospital. This marks the introduction of Erenumab, the world's first fully human monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, to patients in mainland China within the Greater Bay Area, providing a new medication option for clinical migraine treatment.

"Disabling Killer"Migraines Occur More Frequently in Women Clinical Urgently Needs Innovative Drugs for Prevention and Treatment

Migraine is a common chronic neurovascular disease, characterized by recurrent, unilateral or bilateral throbbing severe headaches, accompanied by other symptoms such as photophobia, phonophobia, nausea, and vomiting. The most common locations for the pain are the orbital, frontal, and temporal regions.^[1], and often occurs simultaneously in two or more areas. For the majority of patients, migraine attacks have specific triggers or factors that exacerbate headaches, such as missed meals, fatigue, and stress.^[2]。

Migraine is defined by the World Health Organization as the second leading cause of disability in humans, commonly occurring in young and middle-aged adults, with a higher incidence in women than in men. In China, the prevalence of migraine is 9.3%, with a female-to-male ratio of approximately 3:1.^[3]The total number of patients is approximately 130 million, meaning about 1 in every 10 people suffers from migraines.^[4].Migraine often comes with multiple complications in addition to the damage caused by the disease itself, including depression^[5], Cerebrovascular Disease^[6], Sleep Disorders^{[7]-[8][9][10]}etc., bringing disease burden to patients.

World's First TargetedCGRPReceptor monoclonal antibody reduces seizure frequency by half in patients50%Above

Traditional migraine preventive medications are almost all orally administered small-molecule drugs, as is the case globally.The First and Currently OnlyErenumab, a fully human monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, works by blocking the CGRP receptor molecules associated with migraine. It has relatively low potential immunogenicity and its benefits for preventive treatment of migraine are recognized by international academic guidelines.

Data from the DRAGON study, a Phase 3 trial of Erenumab conducted in an Asian population, was disclosed at the 2022 American Academy of Neurology (AAN) annual meeting. The results showed that at 12 weeks of treatment, 47% of patients had a reduction of over 50% in monthly migraine days, significantly higher than the placebo group (OR 1.54 [95% CI, 1.09-2.17], p=0.014). Meanwhile, the overall safety and tolerability profile of Erenumab was similar to that of the placebo group. This study fully confirmed the efficacy and safety of Erenumab in the Asian population.^[11]。

The European Headache Federation and the American Headache Society, two authoritative academic organizations, have separately conducted scientific evaluations of the evidence for CGRP monoclonal antibody drugs in recent years. They concluded that there is substantial evidence supporting the efficacy of CGRP monoclonal antibodies in the preventive treatment of migraine, and they are strongly recommended.^[12],[13]Since its first approval by the FDA in May 2018, Erenumab has been approved in more than 70 countries and regions worldwide.

Professor Gao Qingchun, Director of the Neurology Department at the Second Affiliated Hospital of Guangzhou Medical University, stated: "In recent years, there has been a growing health demand for the early prevention and treatment of migraines. However, most of the drugs currently used for preventive treatment are not indicated specifically for migraine treatment, and patients urgently need medications that can effectively prevent migraine attacks over the long term. The introduction of Erenumab addresses this unmet medical need, allowing migraine patients in the Greater Bay Area to be among the first to access innovative drugs aligned with global availability, thereby improving their quality of life."

Professor Zhonglin Liu, Chief Physician of the Neurology Department at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, stated: "Erenumab is administered through subcutaneous injection, once a month. Patients can complete the administration process within 15 seconds with simple operation. Erenumab can take effect as early as the first week of treatment. For many migraine patients, this method of administration is both convenient and quick, and the accessibility of the drug has been effectively improved."

Riding the Fast Track in the Greater Bay Area, Erenumab"Settle"Highlighting Innovative Potential

"Greater Bay Area (GBA) Drug and Medical Device Access Scheme" has been implemented in the GBA for nearly two years, adhering to the principle of "step-by-step implementation and pilot first." Its coverage continues to expand, benefiting an increasing number of patients. The "Work Plan for Innovation and Development of Pharmaceutical and Medical Device Regulation in the Guangdong-Hong Kong-Macao Greater Bay Area" points out that by 2035, a comprehensive regulatory coordination mechanism for pharmaceuticals and medical devices within the GBA will be established. Many innovative drugs have been introduced to the GBA through the "GBA Drug and Medical Device Access Scheme" policy, and from this base point, they are radiating across China, enabling the fastest possible access for patients in China to use international innovative drugs simultaneously.

Dr. Alastair Mah, Vice President of United Family Healthcare, stated: "As one of the five mainland China designated medical institutions under the ‘Hong Kong-Macao Medicine and Device Connect’ initiative, Guangzhou United Family Hospital is delighted to leverage national policy to introduce Erenumab, allowing a broad range of patients priority access. The country is actively promoting the development of the Guangdong-Hong Kong-Macao Greater Bay Area, and the introduction of more innovative drugs through the ‘Hong Kong-Macao Medicine and Device Connect’ policy is great news for patients. In the future, United Family Hospitals will continue to introduce more advanced medications, striving to align with international standards."

Zhang Ying, President of Novartis Innovative Drugs China, stated: "Novartis has always been at the forefront of transformative innovation, committed to bringing breakthrough new drugs to Chinese patients as soon as possible. I am delighted to see the rapid availability of Erenumab in the Guangdong-Hong Kong-Macao Greater Bay Area, offering many migraine patients a new option for preventive treatment. With years of deep involvement in the field of central nervous system disorders, we will continue to leverage global resources and local expertise to minimize the time it takes for innovative products to reach China, enabling patients to regain their health sooner."

[1] Kelman L. Headache 2005;45:1038–47.

[2] Shulman KJ et al. Cephalalgia 2018;38 (Suppl. 1):1–115: Abstract MTIS 2018-012 (and associated poster at MTIS, 2018);

[3] Yu Shengyuan. Understanding Headache from Macro to Micro [J]. Chinese Journal of Pain Medicine, 2014, 20(01): 2-4.

[4] Shengyuan Yu, et al. The journal of Headache and pain, 2020,21:53

[5] Expert Consensus on Diagnosis and Treatment of Comorbid Migraine and Depressive Disorders in China, Chinese Journal of Pain Medicine, 2020, 26(12):881-90; Qu Yuan, Hu Hua, Zhou Yiying. Chongqing Medicine 2012.41(10),1029-1030

[6]2019 Chinese Guidelines for Primary Prevention of Cerebrovascular Diseases Chinese Society of Neurology, Chinese Journal of Neurology 2019, 52(9): 684-709

[7]Morgan I et al. J Headache Pain 2015;16:18

[8]Karthik N et al. J Neurol Sci 2012;321:73–76

[9]Sadeghniiat K, et al. Acta Med Iran 2013;51:784–88

[10]Duman T et al. Ann Indian Acad Neurol 2015;18:298–302;

[11] Wang Sj, Kim BK, Wang H, et al. Efficacy and Safety of Erenumab 70 mg in Adult Patients with Chronic Migraine: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled DRAGON Study. Present at 2022 AAN Annual Meeting. S31.005.

[12] Jessica Ailani, Rebecca C. Burch, Matthew S. Robbins, on behalf of the Board of Directors of the American Headache Society. Headache. 2021;61:1021–1039.

[13] Sacco et al. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. The Journal of Headache and Pain (2019) 20:6