Amgen and Novartis present new data demonstrating long-term efficacy, safety and tolerability of Aimovig TM (erenumab-aooe) in patients with chronic and episodic migraine

AmgenAmgen (NASDAQ:AMGN) today announced that the results of two open-label extension (OLE) studies of AimovigTM (erenumab-aooe) in patients with chronic and episodic migraine, respectively, will be presented at the 60th Annual Scientific Meeting of the American Headache Society (AHS) in San Francisco. Results from a one-year study in chronic migraine patients reinforced the established safety and efficacy profile of Aimovig in long-term use. In addition, a three-year interim analysis from an ongoing five-year study of episodic migraine patients, the longest running study of a calcitonin gene-related peptide (CGRP) therapy, reinforced the long-term safety and tolerability of Aimovig. Aimovig is the first and only FDA-approved therapy targeting the CGRP pathway.

In the one-year OLE study in chronic migraine, the primary and secondary outcome measures of the study were long-term safety and efficacy, respectively.(1) The safety results after one year were consistent with the established safety profile of Aimovig in previous studies. The most frequent adverse events (AEs) greater than 2.0 per 100-subject-years were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, arthralgia and migraine. In the double-blind treatment phase, no differences were observed in the safety events between Aimovig and placebo.

The efficacy data showed sustained benefits up to one year. Patients taking Aimovig 140 mg and 70 mg (based on last dose received) achieved reductions of average monthly migraine days of 10.5 and 8.5 days, respectively, compared to a baseline of 18.1 (at the time of enrollment into the placebo-controlled study, after one year of treatment). Patients treated with Aimovig experienced reductions in monthly migraine days of:

  • 50 percent or more: 67 percent on 140 mg and 53 percent on 70 mg
  • 75 percent or more: 42 percent on 140 mg and 27 percent on 70 mg
  • 100 percent reduction: 13 percent on 140 mg and 6 percent on 70 mg

"These data showing sustained efficacy and consistent safety and tolerability of Aimovig over an extended period of time are important for migraine patients and their clinicians to know," said Stewart J. Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. "Collectively these data reinforce the safety and tolerability of Aimovig, and having a treatment specifically designed for migraine has the potential to truly improve the lives of those living with this neurological disease."

The five-year OLE study in episodic migraine is assessing the long-term safety and tolerability of Aimovig.(2) The results at the three-year interim data analysis showed Aimovig had a safety profile consistent with the spectrum and rate of AEs seen in shorter-term placebo-controlled studies, no new AEs and no new causally-related serious AEs. The most frequent AEs were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, influenza and back pain. There was no increase in cardiovascular events over time and no meaningful changes in systolic/diastolic blood pressure or heart rate up to the ~3.2-year follow-up.(2)

"On the heels of the recent FDA approval of Aimovig for the preventive treatment of migraine in adults, the results of these open-label extension studies are encouraging as they contribute to a growing and extensive body of evidence that support the use of Aimovig across the spectrum of migraine," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These data underscore our commitment to building robust clinical programs in both chronic and episodic migraine that further demonstrate the clinical utility of Aimovig. Our underlying goal is to improve the lives of people living with this debilitating disease."

Additional data in patients with chronic migraine are being presented at the AHS meeting, including long-term efficacy of Aimovig in patients with overuse of acute medication, long-term efficacy of Aimovig in patients who failed prior prophylactic treatment, and efficacy of Aimovig at varying dosage strengths in the Phase 3 STRIVE study.

About the Open-Label Extension Study in Chronic Migraine

After the 12-week randomized, double-blind placebo-controlled parent study, eligible patients could enroll in the OLE study. 451 patients completed the study receiving either Aimovig 70 mg, 140 mg or changing from 70 mg to 140 mg during the course of the study.(1) Of the 609 patients who enrolled in the study, 199 increased their dose from 70 mg to 140 mg by week 28.(1)

The primary outcome measure of the study was long-term safety. The secondary outcome measure was efficacy, as determined by four measures: change from baseline to week 52 in monthly migraine days (MMD), monthly acute migraine-specific medication days, monthly cumulative hours of headache, and proportion of patients achieving at least a 50 percent reduction in MMD.

About the Open-Label Extension Study in Episodic Migraine

Following a 12-week randomized, placebo-controlled phase of a (Phase 2) study of Aimovig in adults with episodic migraine, patients could continue into the open-label extension phase, initially receiving 70 mg Aimovig monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring AEs, electrocardiograms, laboratory assessments and vital signs. Of the 383 patients who enrolled in the open-label extension, 235 patients (61.3 percent) remained in the OLE study at the data cutoff point for this interim analysis, all having received Aimovig for at least three years. The study is continuing for up to five years of treatment.

Safety and efficacy data after four and five years of treatment will be reported in the future.

About AimovigTM (erenumab-aooe)

Aimovig is the only FDA-approved treatment specifically developed to prevent migraine by blocking the CGRP-R, which is associated with migraine. Aimovig has been studied in several large global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention. More than 3,000 patients have participated in the Aimovig clinical program across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.

About Migraine

People with frequent migraine may lose more than half their life to migraine. 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) The 2016 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.(4) Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized and under-treated.(3)

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 and Alzheimer's disease. 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) and AMG 301 (currently in Phase 2 development). 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. Also, the companies are collaborating in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in Alzheimer's disease. The oral therapy CNP520 (currently in Phase 3 for Alzheimer's disease) is the lead molecule and further compounds from both companies' pre-clinical BACE inhibitor programs may be considered as follow-on molecules. 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.

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 biologics manufacturing 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 the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

1. Tepper S, et al. Assessment of the Long-Term Safety and Efficacy of Erenumab During Open-Label Treatment of Subjects With Chronic Migraine. Data presented at 60th Annual Scientific Meeting of the American Headache Society, San Francisco, June 2018.
2. Ashina M, et al. Long-term Safety and Tolerability of Erenumab: Three-plus Year Results from an Ongoing Open-Label Extension Study in Episodic Migraine. Data presented at 60th Annual Scientific Meeting of the American Headache Society, San Francisco, June 2018.
3. Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventative therapy. Neurology. 2007; 68(5):343-9.
4. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;388:1545-1602.

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