In an open-label extension spanning 5 years, the safety profile of erenumab was consistent with the double-blind treatment phase of the study, and there were no increases in adverse event rates.
Results from the 5-year, open-label treatment period of a phase 2 study in episodic migraine prevention showed that erenumab (Aimovig) helped patients achieve sustained reductions in both the number of monthly migraine days (MMD) and the number of days in which therapies were needed for acute migraines.
Amgen and Novartis released the results during the Migraine Trust Virtual Symposium. Erenumab, the first-of-its-kind calcitonin gene-related peptide (CGRP) inhibitor, was approved for sale in the United States and the European Union in 2018. Its safety profile was consistent with the double-blind treatment phase of the study, and there were no increases in adverse event rates over the 5 years.
The 5-year open label extension enrolled 383 patients with episodic migraine who had previously completed the 12-week, double-blind, placebo-controlled trial. Episodic migraine was defined as 4 to 14 migraine days and less than 15 headache days per month.
Results from the extension period were compared with the baseline seen in the double-blind portion. All patients initially received 70-mg erenumab monthly, with 250 patients increasing their dosage to 140 mg monthly.
Among the 216 patients who completed the open-label treatment phase, there was an average MMD reduction of 5.3 days from the baseline of 8.7 days.
By the end of the study, patients who had used acute migraine therapies to treat their migraines saw an average reduction in use of 4.4 days from a baseline of 6.2 days with erenumab.
The most common adverse effects were nasopharyngitis, upper respiratory tract infection, and influenza.
"These important data highlight the sustained efficacy, safety, and tolerability profile of Aimovig, and provide crucial information for patients and doctors managing migraine," said Messoud Ashina, MD, PhD, professor of neurology in the Faculty of Health and Medical Sciences at the University of Copenhagen. "The study reinforces the potential of Aimovig to reduce monthly migraine days over the long term for people living with this debilitating, yet underdiagnosed disease.”
"Aimovig continues to have the longest safety and efficacy trial data among treatments for migraine in the calcitonin gene-related peptide class of medications," said Darryl Sleep, MD, senior vice president, Global Medical, and chief medical officer at Amgen. "These long-term results further demonstrate the potential of Aimovig to help the millions of patients who may be candidates for preventive treatment."
The companies also released interim 2-year results of the open-label extension of the LIBERTY study, which involved patients with episodic migraine taking erenumab who failed 2 to 4 prior preventive treatments. As with the other results, there was sustained efficacy and no increases in adverse events rates.
The phase 3 EMPOwER study results, which highlighted the efficacy and safety of erenumab in adult patients with episodic migraine from Asia, the Middle East and Latin America, were also released.
The Push for Fair Pricing and Reform in Pharmacy Benefit Management
April 3rd 2025Amid growing legislative pressures and industry debates, pharmacy benefit managers (PBMs) are exploring new strategies to enhance transparency, reduce patient costs, and navigate the evolving healthcare landscape.
Read More
The Importance of Examining and Preventing Atrial Fibrillation
August 29th 2023At this year’s American Society for Preventive Cardiology Congress on CVD Prevention, Emelia J. Benjamin, MD, ScM, delivered the Honorary Fellow Award Lecture, “The Imperative to Focus on the Prevention of Atrial Fibrillation,” as the recipient of this year’s Honorary Fellow of the American Society for Preventive Cardiology award.
Listen
Using AI-Driven Strategies to Optimize Specialty Drug Costs, Manage Polypharmacy
April 2nd 2025As health care costs continue to rise, artificial intelligence (AI)-driven solutions are emerging as a powerful tool for managing specialty drug spending and polypharmacy risks, as showcased in recent research presented at the Academy of Managed Care Pharmacy 2025 conference.
Read More
Promoting Equity in Public Health: Policy, Investment, and Community Engagement Solutions
June 28th 2022On this episode of Managed Care Cast, we speak with Georges C. Benjamin, MD, executive director of the American Public Health Association, on the core takeaways of his keynote session at AHIP 2022 on public health policy and other solutions to promote equitable health and well-being.
Listen
How Recent Federal Policy Changes Are Shaping Managed Care Pharmacy
April 2nd 2025Federal legislative and regulatory changes are reshaping pharmacy practice, with key challenges in government funding, pharmacy benefit manager reform, and health care policy shifts—topics explored by experts at the Academy of Managed Care Pharmacy's annual meeting.
Read More
The IRA’s Unintended Consequences for Drug Pricing and Coverage
April 2nd 2025The Inflation Reduction Act (IRA) may be restricting Medicare Part D formularies, increasing patient costs, and stifling pharmaceutical innovation, experts warned at the Academy of Managed Care Pharmacy 2025 annual meeting.
Read More