Amgen Announces Five-Year Data That Reinforce The Safety And Efficacy Profile Of Aimovig (erenumab-aooe) In Adult Patients With Episodic Migraine
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
- 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.
- Russo AF.?Annu Rev Pharmacol Toxicol. 2015;55:533-552.
- Diamond S, Bigal ME, Silberstein S, et al. Patterns of diagnosis and acute and preventive treatment for migraine in?the United States: results from the American Migraine Prevalence and Prevention study. Headache. 2007;47(3):355-363.
- Aimovig??(erenumab-aooe) prescribing information,?Amgen,?April 2020.
- Data on File.?Amgen.?July 2020.
- Buse DC, Manack AN, Fanning KM, et al. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study.?Headache. 2012;52(10):1456-1470.
- 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.
- Wang S-J,?Roxas Jr, A, Saravia B, et al. Efficacy and Safety of Erenumab in Patients with Episodic Migraine from the EMPOWER Study. Presented at the 18th Migraine Trust Virtual Symposium;?October 3-9, 2020;?London, U.K.
- 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.
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SOURCE?Amgen