Amgen has reported positive long-term data from a Phase II clinical trial of Aimovig (erenumab-aooe) in patients with episodic migraine (EM).
Aimovig is designed to target the calcitonin gene-related peptide (CGRP) receptor associated with migraine. It is jointly marketed by Amgen and Novartis in the US.
The data from the Phase II study’s five-year open-label treatment phase demonstrated that Aimovig led to sustained benefits, including a reduction in monthly migraine days (MMD) and in use of acute migraine-specific medication (AMSM), such as triptans.
For the open-label period, 383 participants who completed a 12-week randomised, double-blind, placebo-controlled period (DBTP) were enrolled. All patients were given 70mg Aimovig monthly.
After a protocol amendment to analyse long-term safety of higher dose, 250 patients were given 140mg of the drug monthly.
An average MMD reduction of 5.3 days was observed in 216 patients as compared to the DBTP baseline of 8.7 days.
In addition, patients on AMSM had an average reduction in AMSM usage of 4.4 days versus the DBTP baseline of 6.2 days.
The safety profile in the five-year, open-label phase was consistent with the double-blind trial, without any new safety signals or rise in adverse event rates.
Amgen chief medical officer and Global Medical senior vice-president Darryl Sleep said: “As the first FDA-approved treatment and most prescribed preventive therapy in this class, Aimovig continues to be at the forefront of preventive migraine treatment and clinical research.
“These long-term results further demonstrate the potential of Aimovig to help the millions of patients who may be candidates for preventive treatment.”
These long-term results are being presented at the Migraine Trust Virtual Symposium.
Further Aimovig data, including interim two-year data from the open-label extension study of the LIBERTY trial, and efficacy and safety data from the Phase III EMPOwER trial will also be presented at the symposium.