Benzinga | Nov 9, 2021 11:10AM EST

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

Amgen (NASDAQ:AMGN) today announced new data from the HER-MES study, the first and only head-to-head study of Aimovig(r) (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 Charit? Universit?tsmedizin 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(r) autoinjector, does not require a loading dose and is easy to use.6,7