Teva Pharmaceutical has reported the final analysis of the PEARL Phase IV migraine prevention trial of the anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, Ajovy (fremanezumab), in individuals with chronic and episodic migraine (EM).
The pan-European study’s data confirmed that the primary and secondary endpoints were achieved.
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The primary goal was the proportion of subjects experiencing at least a 50% decrease in the number of monthly migraine days (MMD) in the six months after starting fremanezumab treatment.
Secondary goals included the mean change from baseline in MMD and treatment adherence and persistence rates over 24 months.
The trial involved 1,140 subjects, 33.1% with EM and 66.9% with chronic migraine (CM).
The final data indicated that over 66% of EM patients and 51.6% of CM patients who met the primary goal during the first six months continued to see a significant benefit in migraine prevention for more than 24 months.
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By GlobalDataHigh injection adherence rates of nearly 90% were observed throughout the trial, with more than 75% of subjects completing the full study duration.
According to the investigators, the long-term tolerability and safety profile of the treatment was also consistent with prior interim analyses and randomised controlled studies. This supports the continued clinical use of Ajovy for migraine prevention.
Teva Pharmaceutical Medical Affairs Europe head and vice-president Pinar Kokturk said: “The final analysis of the PEARL real-world study reaffirms the long-term effectiveness and safety profile of fremanezumab in the preventive treatment of chronic and episodic migraine.
“These data provide valuable real-world evidence supporting fremanezumab’s sustained clinical benefit, particularly in a population burdened by high disease impact and a need for preventive therapy.”
Last year, Teva reported positive outcomes from the Phase III SPACE trial of Ajovy as a preventive treatment for EM in young patients aged six to 17 years old.
