First And Only Randomized, Double-blind, Head-to-head Study Comparing Aimovig® (erenumab-aooe), An Anti-CGRP Pathway Therapy, To Topiramate Published In Cephalalgia

Aimovig Demonstrated Superiority for Both the Primary and Secondary Endpoint Versus Topiramate
Aimovig had a Significantly Lower Discontinuation Rate Due to Adverse Events Versus Topiramate
More Patients in the Aimovig Treatment Arm Achieved at Least a 50 Percent Reduction in Monthly Migraine Days From Baseline Compared to Those in the Topiramate Treatment Arm

Amgen today announced new data from the HER-MES study, the first and only head-to-head study of Aimovig® (erenumab-aooe), a calcitonin gene-related peptide (CGRP) inhibitor, against topiramate for adult patients with episodic and chronic migraine. Topiramate is one of the most commonly prescribed medications in migraine prevention with an estimated 600,000 new-to-brand prescriptions written in the U.S. each year.1,2 Published in Cephalalgia, the results of the study conducted by Novartis showed that patients in the Aimovig treatment arm experienced a significantly lower discontinuation rate due to adverse events and superior efficacy, with a greater proportion of patients achieving at least a 50 percent reduction from baseline in their monthly migraine days (MMDs), compared with topiramate.3

“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, M.D., Ph.D., MBA, trial investigator and managing medical director at Charité Universitätsmedizin in Berlin. “The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.”

In this head-to-head Phase IV study, patients in the Aimovig arm demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm (10.6% versus 38.9%). Additionally, significantly more patients in the Aimovig arm achieved at least a 50% reduction from baseline in their MMDs than those in the topiramate group (55.4% versus 31.2%). In the topiramate group, the most frequent adverse events that led to discontinuation of the study medication were paraesthesia, disturbance in attention, fatigue, and nausea. In the Aimovig group, these were fatigue, nausea, disturbance in attention and dizziness. Additional study treatment-related adverse events reported by ≥2% in any trial group included constipation, decreased appetite, taste disorder, vertigo, dysgeusia, weight loss, dry mouth, irritability, mood swings, diarrhea, depression, sleep disorder, depressed mood, hypoesthesia, upper abdominal pain, aphasia, insomnia, memory impairment, dyspepsia, dysesthesia and headache.3

“We’re extremely encouraged by these new results, which demonstrate lower discontinuation rates due to adverse events and superior efficacy versus topiramate in migraine prevention and strengthen our confidence that Aimovig has significant potential to help many more patients living with migraine,” said Rob Lenz, M.D., Ph.D., senior vice president of Global Development at Amgen. “Amgen is dedicated to helping the millions of people who live with this debilitating neurological disease get back to what’s important to them while living with more migraine-free days.”

Migraine is a highly debilitating disease that has a significant impact on people’s lives, including time spent with family and friends, or at work.4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 It is self-administered once monthly subcutaneously via the SureClick® autoinjector, does not require a loading dose and is easy to use.6,7

HER-MES (NCT03828539) is the first randomized, double-blind, double-dummy, active-controlled, parallel-group Phase IV study to assess tolerability (as assessed by the discontinuation rates due to adverse events) and efficacy of Aimovig versus topiramate in a patient-centered setting.3 The primary endpoint was treatment discontinuation rate due to adverse events of 70 mg and 140 mg Aimovig monthly compared with 50 to 100 mg topiramate daily during the double-blind treatment phase of the study.3 The secondary endpoint was efficacy of 70 mg and 140 mg Aimovig monthly versus 50 to 100 mg topiramate daily in terms of at least a 50% reduction in monthly migraine days from baseline in the last three months (months 4, 5 and 6) of the double-blind, 24-week treatment phase.3 The HER-MES study enrolled 777 adult patients with episodic or chronic migraine (≥4 migraine days per month) who had not previously received migraine prevention treatment or had failed up to three previous therapies with propranolol/metoprolol, amitriptyline and/or flunarizine.3 After the 2-week screening and 4-week baseline phase, patients received either Aimovig subcutaneously and topiramate placebo orally or topiramate orally and Aimovig placebo subcutaneously.

About Aimovig® (erenumab-aooe)
Aimovig is the first FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.6 Aimovig has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention.8,9 Aimovig is self-administered once monthly via the easy-to-use SureClick® autoinjector, without a required loading dose.6,7 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.8-13

About Migraine
People with frequent migraine attacks may lose more than half their life to migraine.17,16 They endure debilitating pain, physical impairment, and can live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.5,17 The 2019 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.18 Migraine is associated with personal and societal burdens of pain, disability and financial cost, and it remains under-recognized and under-treated.5,19

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.

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