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Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In Second Phase 3 Study
"Migraine is ranked one of the most debilitating diseases by the
Patients enrolled in STRIVE were randomized to receive either placebo, or one of two erenumab doses – 70 mg or 140 mg – subcutaneously, once monthly for six months. At baseline, patients were experiencing an average of 8.3 migraine days per month. Patients in the erenumab 70 mg and 140 mg treatment arms experienced reductions of 3.2 and 3.7 days from baseline in monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.These results were statistically significant.
The safety profile of erenumab was comparable to placebo across both treatment arms and was consistent with previously reported studies. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and sinusitis.
Further analysis of STRIVE data is ongoing and will be submitted to a future medical conference and for publication.
Two other positive trials—ARISE, a Phase 3 study of erenumab in episodic migraine prevention, and the Phase 2 study of erenumab in chronic migraine prevention—were announced earlier this year. Combined together, almost 2,200 patients with chronic and episodic migraine have participated in these three erenumab clinical trials. These data will help support discussions with regulatory agencies, with filing anticipated in 2017.
Erenumab is being co-developed by
STRIVE (20120296) is a global Phase 3, multicenter, randomized 24-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in episodic migraine prevention. In the study, 955 patients were randomized to receive once-monthly subcutaneous placebo or erenumab (70 mg or 140 mg) in a 1:1:1 ratio. Patients enrolled in STRIVE were experiencing an average of 8.3 migraine days per month. The primary endpoint was change in mean monthly migraine days from baseline over the last three months of the double-blind treatment phase of the study (months 4, 5, 6). Secondary study endpoints assessed at six months included reduction of at least 50 percent from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in both mean impact on everyday activities domain and mean physical impairment domain scores on the Migraine Physical Function Impact Diary (MPFID).
Erenumab is a fully human monoclonal antibody specifically designed for the prevention of migraine. Erenumab targets and blocks the Calcitonin Gene-Related Peptide (CGRP) receptor, thought to be pivotal in the genesis of migraine. Erenumab is being studied in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention.
People with migraine face intolerable pain and physical impairment, which is frequently accompanied by nausea, vomiting and significant disruption of daily activities.1
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.
This news release contains forward-looking statements that are based on the current expectations and beliefs of
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3 GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016; 388: 1545–602.
4 Diamond S et al. Patterns of diagnosis and acute and preventive treatment for migraine in
5 Stovner L et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007; 27: 193-210.
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