THOUSAND OAKS, Calif., Oct. 3, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that results reinforcing the long-term safety and efficacy profile of Aimovig® (erenumab-aooe) in patients with episodic migraine (EM) are being presented at the Migraine Trust Virtual Symposium. Results from the five-year, open-label treatment period of a Phase 2 study in episodic migraine prevention (NCT01952574) showed Aimovig helped patients achieve sustained reductions in monthly migraine days (MMD) and in use of acute migraine-specific medication (AMSM), such as triptans. Additionally, the safety profile was consistent with what was observed in the double-blind treatment phase of the study, with no increases in adverse event rates over five years of exposure.1
“These important data highlight the sustained efficacy, safety and tolerability profile of Aimovig, and provide crucial information for patients and doctors managing migraine,” said Dr. Messoud Ashina, professor of neurology in the Faculty of Health and Medical Sciences at the University of Copenhagen. “The study reinforces the potential of Aimovig to reduce monthly migraine days over the long term for people living with this debilitating, yet underdiagnosed disease. For my patients, more migraine-free days means they’re able to get back to the things that are important to them, like spending more time with family and friends, and being able to go to work.”1-4
The five-year, open-label treatment phase enrolled 383 patients with episodic migraine who completed a 12-week double-blind, placebo-controlled treatment period (DBTP).1 Among the 216 patients who completed the open-label treatment phase, there was an average MMD reduction of 5.3 days from the DBTP baseline of 8.7 days.1 By the end of the study, patients who used AMSM to treat their migraine headaches experienced an average reduction in AMSM use of 4.4 days from the DBTP baseline of 6.2 days.1 The most common side effects were nasopharyngitis, upper respiratory tract infection, and influenza.1
“Aimovig continues to have the longest safety and efficacy trial data among treatments for migraine in the calcitonin gene-related peptide class of medications,” said Darryl Sleep, M.D., senior vice president, Global Medical, and chief medical officer at Amgen. “Many people with this debilitating neurological disease live in dread of the next attack.3 As the first FDA-approved treatment and most prescribed preventive therapy in this class, Aimovig continues to be at the forefront of preventive migraine treatment and clinical research.5,6 These long-term results further demonstrate the potential of Aimovig to help the millions of patients who may be candidates for preventive treatment.”1,2,7,8
Additional studies highlighting Aimovig will be presented at the Migraine Trust Virtual Symposium, including interim results of the LIBERTY open-label extension study, as well as efficacy and safety results of Aimovig in the EMPOwER study. These studies reinforce the safety and efficacy profile of Aimovig for patients of various backgrounds across the episodic migraine spectrum.
- Interim two-year results of the open-label extension study of the LIBERTY study (NCT03096834) showed sustained efficacy and no increases in adverse events rates for patients with episodic migraine taking Aimovig who failed 2-4 prior preventive treatments.9
- Results of the Phase 3 EMPOwER study (NCT03333109) highlighted the efficacy and safety of Aimovig in adult patients with episodic migraine from Asia, the Middle East and Latin America.10,11
About the Open Label Extension Phase of the Phase 2 Study in Episodic Migraine Prevention (NCT01952574)
After a 12-week randomized, double-blind, placebo-controlled period, 383 eligible adult patients with episodic migraine (defined in the trial as 4 to 14 migraine days and less than 15 headache days per month at baseline) were enrolled in the open-label treatment phase.1,12 All patients initially received 70 mg Aimovig monthly, with 250 patients increasing their dosage to 140 mg monthly after a protocol amendment to assess long-term safety of the higher dose.1,12,13 Safety and tolerability were assessed by monitoring adverse events, electrocardiograms, laboratory assessments, and vital signs.1
No new safety signals or increases in adverse event rates were observed over five years of exposure with Aimovig as compared to the DBTP, in which the safety and tolerability profiles of Aimovig were in line with other clinical trial data.1 The most common side effects were nasopharyngitis, upper respiratory tract infection, and influenza.
About Aimovig® (erenumab-aooe)
Aimovig, co-marketed in the U.S. by Amgen and Novartis, is the first and only FDA and EMA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.5,14 Aimovig has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention.15,16 Aimovig is self-administered once monthly via the easy-to-use SureClick® autoinjector, without a required loading dose.16 More than 3,000 patients participated in registrational trials of Aimovig across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.1,9,10,15,16
Aimovig is also being evaluated through CATALYST, a comprehensive evidence generation program initiated by Amgen and Novartis that includes over 7,500 patients across 14 ongoing clinical trials and a robust assessment of real-world evidence. Spanning over 39 countries globally, CATALYST clinical trials will explore the role of Aimovig in comparative studies, assessing impact on novel migraine outcomes, understanding predictive biomarkers and expanding Aimovig’s use in additional study populations. To date, more than 440,000 patients across 44 countries worldwide have been prescribed Aimovig for the preventive treatment of migraine in adults.18
Aimovig® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.
Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig® and initiate appropriate therapy.
Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.
Monitor patients treated with Aimovig® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.
Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of Aimovig® in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. Aimovig® was discontinued in many of the reported cases.
Monitor patients treated with Aimovig® for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of Aimovig® is warranted if evaluation fails to establish an alternative etiology.
Adverse Reactions: The most common adverse reactions in clinical studies (≥ 3% of Aimovig®-treated patients and more often than placebo) were injection site reactions and constipation.
Please see Aimovig® full Prescribing Information.
People with frequent migraine attacks may lose more than half their life to migraine.12 One attack could last up to three days.12 They 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.3,19 The 2017 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.20 Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized and under-treated.2,4
About Amgen and Novartis Neuroscience Collaboration
In August 2015, Amgen entered into a global collaboration with Novartis to develop and commercialize pioneering treatments in the field of migraine. The collaboration focuses on investigational Amgen drugs in the migraine field, including Aimovig (approved by the FDA in May 2018 for the preventive treatment of migraine in adults).5 In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the U.S. For the migraine programs, Amgen retains exclusive commercialization rights in the U.S. (other than for Aimovig as described above) and Japan, and Novartis has exclusive commercialization rights in Europe, Canada and rest of world. At the center of the Amgen and Novartis neuroscience collaboration is the shared mission to fight migraine and the stereotypes and misperceptions surrounding this debilitating disease.
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Amgen Forward-Looking Statements
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CONTACT: Amgen, Thousand Oaks
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- Ashina M, Goadsby P, Reuter U, et al. Sustained efficacy and long-term safety of erenumab in patients with episodic migraine: results of a 5-year, open-label extension study. Presented at the 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
- Lipton R, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5)343-9.
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- Aimovig® (erenumab-aooe) prescribing information, Amgen, April 2020.
- Data on File. Amgen. July 2020.
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- US Census Bureau. Age and Sex 2012-2016 American Community Survey 5-Year Estimate. https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk. Accessed August, 19, 2020.
- Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Sustained Efficacy and Safety of Erenumab in Episodic Migraine Patients Failing 2–4 Prior Preventive Treatments: 2-year Interim Results of the LIBERTY Open-Label Extension Study. Presented at the 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
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- Wang S-J, Roxas Jr A, Saravia B, et al. Baseline demographics and disease characteristics from the Phase 3 EMPOwER study in patients with episodic migraine in Asia, Middle East and Latin America. Presented at the 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
- Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
- Ashina M, Goadsby P, Reuter U, et al. Sustained efficacy and long-term safety of erenumab in patients with episodic migraine: 4+ year results of a 5-year, open-label treatment period. Presented at the International Headache Congress (IHC); September 5–8, 2019; Dublin, Ireland.
- Olesen J, Diener HS, Husstedt I, et al. Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Engl J Med. 2004;350(11):1104-1110.
- Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382-390. doi:10.1016/S1474-4422(16)00019-3
- Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425-434. doi:10.1016/S1474-4422(17)30083-2
- Data on File. Amgen. March 2019.
- Data on File. Novartis. July 2020.
- Rutberg S, Ohrling K. Migraine – more than a headache: Women’s experiences of living with migraine. Disabil Rehabil. 2012;34(4):329-336.
- GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1789-1858.