Teva Pharmaceutical Industries has announced the conclusive results of the PEARL Phase 4 study, revealing that Ajovy (fremanezumab) effectively reduces migraine frequency and severity over a two-year period.
Presented at the European Academy of Neurology Congress in Helsinki, the data confirmed that both primary and secondary goals of the study were met, demonstrating prolonged effectiveness and high adherence to fremanezumab treatment.
Teva vice president and Europe medical affairs head 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. With migraine being the second leading cause of disability worldwide, the recognition of CGRP-pathway therapies by health authorities is critical for improving patient outcomes.”
Conducted over 24 months, the real-world observational PEARL study evaluated fremanezumab’s impact on 1,140 patients, predominantly female, with chronic (66.9%) and episodic (33.1%) migraines.
The study findings indicated that more than 66% of episodic migraine patients and over 51% of chronic migraine patients achieved a primary endpoint of at least a 50% reduction in monthly migraine days within the initial six months. These patients maintained prevention benefits for two years.
Injection adherence remained high at approximately 90%, with over three-quarters of participants completing the study.
Investigators also highlighted fremanezumab’s favourable long-term safety and tolerability profile, which aligns with previous interim analyses and randomised controlled trials. These findings support its ongoing clinical application for migraine prevention.
Ajovy is designed for adults experiencing at least four migraine days per month and is available as a single-dose injection.
Available dosing options include 225 mg once monthly or 675 mg every three months, with administration possible by a healthcare professional or patient at home, without needing a starting dose.
The study engaged adults maintaining a headache diary throughout the period, focusing on a primary endpoint of achieving a 50% reduction in monthly migraine days within six months. Secondary assessments included changes in monthly migraine days from baseline and adherence to prescribed dosing schedules.
