THOUSAND OAKS, CA, USA I November 16, 2016 I Amgen (NASDAQ:AMGN) today announced positive top-line results for erenumab from a global Phase 3, randomized, double-blind, placebo-controlled STudy to evaluate the efficacy and safety of erenumab in migRaIne preVEntion (STRIVE). These data showed the STRIVE study met the primary endpoint, demonstrating statistically significant reductions from baseline in monthly migraine days in patients with episodic migraine treated with either 70 mg or 140 mg erenumab compared with placebo. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor, which is believed to have a critical role in mediating the incapacitating pain of migraine.
“Migraine is ranked one of the most debilitating diseases by the World Health Organization, yet it is often under-diagnosed and under-treated. People who experience migraine battle the disease for many years and it has significant impact on their everyday activities,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The results of this study are important because they confirm the results from our previous studies and add to our body of research in episodic migraine. We look forward to working with regulatory authorities to pursue approval of erenumab and making this novel migraine prevention treatment available to patients and physicians.”
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 Amgen and Novartis. As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and rest of world.
About STRIVE
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).
About Erenumab
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.
About Migraine
People with migraine face intolerable pain and physical impairment, which is frequently accompanied by nausea, vomiting and significant disruption of daily activities.1 The World Health Organization ranks migraine as one of the most debilitating illnesses.2 Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized and under-treated, with more than 40 percent of people going undiagnosed.3,4 Worldwide, approximately 90 percent of people diagnosed with migraine have episodic migraine, which is characterized by up to 14 migraine days a month.5,6 The remaining 10 percent have chronic migraine, which is characterized by at least 15 headache days per month, of which eight or more are migraine days, for more than three months.
About Amgen and Novartis Neuroscience Collaboration
In August 2015, Amgen entered into a global collaboration with Novartis to jointly develop and commercialize pioneering treatments in the field of migraine and Alzheimer’s disease (AD). The collaboration focuses on investigational Amgen drugs in the migraine field, including erenumab (currently in Phase 3 studies for episodic migraine as well as open-label studies in episodic and chronic migraine) and AMG 301 (currently in a Phase 1 study). For the migraine program, Amgen retains commercialization rights in the U.S., Canada and Japan, and Novartis has commercialization rights in Europe and rest of world. Also, the companies are partnering in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD. Novartis’ oral therapy CNP520 (currently in a Phase 2 study for AD) will be the lead molecule and further compounds from both companies’ pre-clinical BACE inhibitor programs may be considered as follow-on molecules.
About Amgen
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.
References
1Migraine Research Foundation. Migraine Fact Sheet. http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed November 2, 2016.
2 World Health Organization. Headache disorders. http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed November 2, 2016.
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 the United States: results from the American Migraine Prevalence and Prevention Study. Headache. 2007; 47:355-363.
5 Stovner L et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007; 27: 193-210.
6 Headache Classification Committee of the International Headache Society (IHS). Cephalalgia. 2013;33:629-808.
SOURCE: Amgen
