2021-11-09| Trials & Approvals

Amgen Announces Encouraging Full Data for Migraine Drug, Aimovig

by Rajaneesh K. Gopinath
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In November 2020, positive Phase IV results of Aimovig, the migraine drug co-commercialized by Novartis and Amgen was reported. The HER-MES study that evaluated Aimovig against treatment standard, topiramate for adult patients with episodic and chronic migraine, found that the drug achieved superiority in its primary and secondary endpoints.

A year later, the complete data is now released by the companies. Results 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.

“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.”

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First FDA-Approved Migraine Drug Targeting the CGRP Receptor

Migraine is caused by the release of inflammatory substances in the brain that manifests as severe headaches, accompanied by nausea and vomiting. The neurological disorder is the second leading cause of disability worldwide and the third most common disease, affecting more than 10% of the global population.

Aimovig bagged approval from the FDA for migraine treatment in May 2018. It is the first FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.

The HER-MES study showed that patients treated with Aimovig demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm (10.6% versus 38.9%). Besides, more patients in the Aimovig arm achieved at least a 50% reduction from baseline in their MMDs compared to the topiramate group (55.4% versus 31.2%).

In the topiramate group, the most frequent adverse events that led to the 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.

“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.”

In spite of these encouraging results, Aimovig has to deal with competition from various treatment options for migraine. Just a few months after its approval, Teva’s Ajovy became the second anti-CGRP treatment to be approved by the FDA.

In 2019, Eli Lilly’s Reyvow notched FDA approval as the first medicine in a new class of acute treatment for migraine that targets the serotonin (5-HT)1F receptor. Soon after, Allergan’s Ubrelvy, another CGRP targeting migraine drug received market approval, followed by Biohaven’s Nurtec ODT, an oral CGRP drug. It remains to be seen, how Aimovig can withstand the crowded market.

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