The study was momentous in that it was the first head-to-head comparison of two modalities. The Aimovig showed significantly good results and aced primary endpoints.
Aimovig is the new hope for migraine sufferers.
There’s promising news this morning for migraine sufferers, as Amgen announced that its approved therapy, Aimovig® (erenumab-aooe), more than held its ground against one of the most commonly prescribed migraine medications.
In the first and only head-to-head study of Amgen’s calcitonin gene-related peptide (CGRP) inhibitor against topiramate, the former proved more effective and was better tolerated in adult patients with episodic and chronic migraine.
Study Results of Aimovig
In the phase IV study conducted by Novartis, Amgen’s former partner, Aimovig aced both primary endpoints, demonstrating a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm, and also displaying higher efficacy. Just 10.6% of patients receiving Aimovig discontinued the drug due to adverse events, compared with 38.9% in the topiramate arm. In addition, 55.4% of patients taking Aimovig enjoyed at least a 50% reduction from baseline in monthly migraine days (MMD). This was nearly 20 points higher than the 31.2% of patients receiving topiramate who saw a 50% reduction.
The most common adverse events causing discontinuation in the Aimovig arm were fatigue, nausea, disturbance in attention and dizziness. Full data was published in the journal Cephalalgia.
The study on the Aimovig drug was momentous in that it was the first head-to-head comparison of two modalities.
“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Dr. 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.”
Migraine headaches are a common, debilitating condition that reduces the quality of life for millions of people. According to the Centers for Disease Control, migraines are considered one of the leading causes of disability worldwide. In 2018, the prevalence of migraine in the U.S. was 15.9% across all adults, with more women (21%) than men (10.7%) being affected.
“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 Dr. 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.”
Aimovig, the first FDA-approved migraine preventive treatment that targets the CGRP receptor, was approved by the U.S. Food and Drug Administration for adults in 2018. It is self-administered once a month.
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