Pfizer's Next-Gen CGRP Receptor Antagonist Nurtec® (Rimegepant ODT) Approved in China for Acute Treatment of Migraine

On January 26, 2024, Pfizer, Inc. announced that its next-generation specific migraine treatment drug, Rimegepant Orally Disintegrating Tablets (trade name: Lataik), received approval from the China National Medical Products Administration (NMPA) for the acute treatment of migraines with or without aura in adults. As the world's first and only calcitonin gene-related peptide (CGRP) receptor antagonist utilizing patented orally disintegrating tablet technology, Lataik (Rimegepant Orally Disintegrating Tablets) effectively blocks key pathways associated with migraine onset, providing rapid and sustained relief from headaches and related symptoms. It is convenient to administer and has no contraindications related to cardiovascular diseases. Lataik (Rimegepant Orally Disintegrating Tablets) is also the only drug globally approved by both the U.S. FDA and the European EMA for both acute treatment and preventive treatment of migraines, and it has been recommended by migraine guidelines in the United States, Europe, and China. Notably, the "Chinese Guidelines for the Diagnosis and Treatment of Migraine (2022 Edition)" strongly recommends it as a Level 4 recommendation for both acute and preventive treatment, offering a new therapeutic option for a broader population of migraine patients.

<Jean-Christophe Pointeau, Senior Vice President of Pfizer Global and President of Pfizer China>

Jean-Christophe Pointeau, Senior Vice President of Pfizer Global and President of Pfizer China, stated: "Neuroscience is a key focus for Pfizer's in-depth development and expansion globally. In the field of migraine treatment, Pfizer has a pipeline of groundbreaking innovative drugs. Rimegepant Orally Disintegrating Tablets (trade name: Nurtec) is the first next-generation specific migraine treatment drug to enter China. Targeting Calcitonin Gene-Related Peptide (CGRP), combined with innovative orally disintegrating technology, it addresses previous issues of insufficient efficacy and safety in migraine treatments. As the world’s only CGRP receptor antagonist orally disintegrating tablet to date, Nurtec (Rimegepant Orally Disintegrating Tablets) represents a new breakthrough in migraine treatment, offering Chinese clinicians and patients a novel therapeutic option. This year marks Pfizer's 35th anniversary in China, and we are delighted to start the New Year with the approval of Nurtec (Rimegepant Orally Disintegrating Tablets). The approval of this drug will tangibly help Chinese migraine patients improve clinical outcomes and enhance their quality of life. It also exemplifies Pfizer's unwavering commitment to its mission of 'delivering breakthrough innovations that change patients' lives,' by deeply rooting itself in China to serve Chinese patients. Moving forward, we will continue to uphold the principle of 'patient-centered care,' further improving the accessibility and affordability of innovative drugs. We will collaborate closely with industry partners and all sectors of society to jointly build an innovative ecosystem for migraine diagnosis and treatment, contributing to the early realization of ‘Healthy China 2030’ and promoting high-quality development in China's healthcare sector."

<Professor Wang Yonggang, Director of the Headache Department at Beijing Tiantan Hospital, Capital Medical University>

Migraine is a common and disabling disease, ranking as the second most common neurological disabling disease globally and the leading cause of disability in people under 50. Currently, due to the lack of specific drugs, the treatment of migraine has significant limitations in terms of efficacy and safety. Not only is the treatment response insufficient and symptoms prone to recurrence, but patients also face risks such as chronic headache and medication-overuse headaches from long-term use of painkillers, as well as contraindications for patients with cardiovascular diseases. There is an urgent need for innovative drugs with good efficacy and safety for the acute treatment of migraine. Professor Wang Yonggang, Director of the Headache Department at Beijing Tiantan Hospital affiliated with Capital Medical University, Chairman of the Headache Cooperation Group of the Neurology Branch of the Chinese Medical Association, and Chairman of the Headache Branch of the Chinese Stroke Association, stated: "New-generation specific treatment options represented by Rimegepant bring new choices for the acute treatment of migraine. The CGRP receptor antagonist Rimegepant not only rapidly relieves acute migraine attacks but also shows a trend of reducing the number of headache days when taken on-demand each month, offering dual benefits to migraine patients and improving their quality of life, allowing them to better return to work and daily life."
Due to its high prevalence, significant disability, and substantial disease burden, migraine has become one of the major public health issues globally. Its symptoms are characterized by recurrent episodes, mostly unilateral, moderate to severe throbbing headaches that typically last 4-72 hours, often accompanied by nausea, vomiting, photophobia, and phonophobia. The global prevalence of migraine is 14.4%, while in China it is 9.3%. Long-term repeated attacks result in serious health losses, decreased quality of life, and reduced productivity. Additionally, migraine is often associated with various complications such as anxiety, depression, cerebrovascular diseases, and sleep disorders, causing an immense disease burden.

Levatek (Rimegepant Orally Disintegrating Tablets) is the first oral CGRP receptor antagonist to demonstrate positive results in a pivotal trial conducted in China. In this study, patients achieved the co-primary endpoints of pain relief and relief from the most bothersome symptoms within two hours after a single oral dose of 75mg. Patients experienced rapid pain relief and elimination of the most bothersome symptoms within 45 minutes, returned to normal function within 60 minutes, and achieved pain freedom within 90 minutes. The effects lasted up to 48 hours for most patients. The drug also demonstrated a favorable safety and tolerability profile, consistent with previous clinical trial results in the United States. As a novel specific treatment, Levatek (Rimegepant Orally Disintegrating Tablets) represents a breakthrough in migraine treatment, not only advancing standardized management and creating a new landscape for migraine diagnosis and treatment in China but also offering new hope for migraine sufferers to return to a healthy life.

To help more migraine patients improve drug affordability and reduce treatment costs, Reyvow (Rimegepant Orally Disintegrating Tablets) has been included in multiple regional insurance plans in 2023, such as Hainan Huiqiong Insurance, Lecheng Special Drug Insurance, Hunan Aimin Insurance, Suzhou Suhui Insurance, Wuxi Yihuixin City, Lanzhou Jinchenghui Medical Insurance, Tangshan Huitang Insurance, Heilongjiang Longjianghui Public Welfare Insurance, as well as the "Cancer Prevention and Treatment Exclusive Insurance Card" for veteran families.