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Erenumab Reduced Monthly Migraine Days for Japanese Patients With Episodic Migraine, Which is Consistent With Global Data
Data Presented at the 46th Congress of the Japanese Headache Society
TOKYO (Nov. 19, 2018) – Amgen Astellas Biopharma K.K. (Head Office: Chiyoda-ku, Tokyo, Japan. President: Steve Sugino, hereafter Amgen Astellas) today announced positive results from a six-month Japanese Phase 2 study (NCT02630459) evaluating erenumab versus placebo for the prevention of episodic migraine (between four and 14 migraine days per month). Erenumab delivered statistically significant differences from placebo for all primary and secondary endpoints in the study. These positive data were presented on Nov. 16, 2018, at the 46th Congress of the Japanese Headache Society.
In this Phase 2 study, 475 Japanese patients, experienced between four and 14 migraine days each month, were randomized to receive once-monthly subcutaneous placebo, or erenumab (28 mg, 70 mg or 140 mg) in a 2:1:2:2 ratio. The mean baseline monthly migraine days (MMD) were ranged between 7.7-8.1 days for each group. The primary endpoint was change from baseline in mean MMD over the last three months of the double-blind treatment phase of the study (months 4, 5 and 6). Patients taking erenumab at the dose of 70 mg and 140 mg experienced a significant reduction in mean MMD (differences from placebo in reduction of mean MMD are 2.3 and 1.9 day, individually, p<0.001). Secondary study endpoints assessed at 3 months included reduction of at least 50 percent from baseline in mean MMD and change from baseline in mean monthly acute migraine-specific medication days. Patients taking erenumab at doses of 70 mg and 140 mg were significantly more likely to achieve a 50 percent or greater reduction in MMD than those taking placebo. Acute migraine-specific medication treatment days were also significantly reduced in the patients taking erenumab. Patients taking erenumab reported significant improvements compared to placebo in HIT-6TM, a patient-reported outcome assessing the impact of migraine on their lives, when taking erenumab.
Erenumab is an investigational fully human monoclonal antibody designed to specifically block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation.
In the study overall, similar frequencies of adverse events and serious adverse events were observed across erenumab and placebo groups. The most frequently reported adverse events (in at least 2 percent of patients in any group) were nasopharyngitis, constipation, pharyngitis, back pain, dental caries, gastroenteritis and upper abdominal pain.
“This is the first study which reported the efficacy as preventives of CGRP-pathway monoclonal antibodies for Japanese migraine patients. Patients treated by the antibody experienced reduced monthly migraine days and also reduced disease burden in their daily life,” said Fumihiko Sakai, M.D., Director, Professor of Saitama International Headache Center, Saitama Neuropsychiatric Institute, Japan. “Globally, the efficacy and safety of CGRP-blocking antibody was confirmed in Ph3 study and the drug is now available as a treatment option of migraine preventives for overseas patients. Meanwhile, only repurposed drugs are currently available in Japan. The results of this Japanese Ph2 study represent a milestone toward providing Japanese patients suffering from migraine with a mechanism-based treatment option in the near future.”
Erenumab has been approved by FDA and European Medicines Agency (EMA) in 2018.
Erenumab is the only treatment specifically designed to prevent migraine by blocking the CGRP receptor, which is associated with migraine activation. Erenumab has been studied in several large global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 3,000 patients have participated in the erenumab clinical program across six placebo-controlled clinical studies and their open-label extensions, including this study.
About Migraine in Japan
People with frequent migraine may lose more than half their life to migraine days.1 Migraine robs individuals of time with their families, productivity at home and at work, and their livelihoods. Migraine sufferers endure debilitating pain, physical impairment, and live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.2 The World Health Organization ranks migraine as one of the most debilitating illnesses.2 In Japan, prevalenve of migraine is estimated to be 8.4 percent.3 Acute treatment is provided to resolve the migraine attack rapidly and restore the patient’s normal functions. Preventive therapy is recommended if disability in daily living due to migraine is not adequately relieved by acute treatment alone. 4 It is reported that only a small proportion of migraine patients in Japan consult medical facilities, even though migraine causes disability in everyday life.4,
About Amgen Astellas Biopharma K.K.
Amgen Astellas BioPharma K.K.（http://www.aabp.co.jp/jp/） is a Japanese company that began operations on Oct. 1, 2013, to provide breakthrough-science-based medicines to help address unmet medical needs of patients in Japan. The company is a joint venture between Amgen, one of the world’s leading independent biotechnology companies, and Astellas Pharma Inc., a leading Tokyo-based R&D oriented global pharmaceutical company. AABP has grown into an organization with over 400 employees and comprehensive functions to be fully operational as a marketing authorization holder in Japan. The joint venture will become a wholly-owned Amgen affiliate as soon as 2020.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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