New AJOVY® Migraine Prevention Data Questions Treatment Pauses

Teva Pharmaceutical Industries Ltd. has unveiled new findings from the 4th interim analysis of the PEARL study on migraine prevention using AJOVY® (fremanezumab). These results could question the practice of pausing treatment with calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs), a pause often required or suggested by some reimbursement authorities after a year of continual use.

The PEARL study's sub-analysis examined the effects of stopping and restarting fremanezumab on monthly migraine days (MMD) among adults with episodic or chronic migraine. The findings indicate that halting treatment could lead to an increase in MMD and a reduction in treatment effectiveness once it is resumed, compared to the initial treatment cycle. Key observations from the analysis include:

- Over 40% of patients experienced a sharp increase in migraine frequency (>=50% rise in MMD) within the first two months after stopping treatment.
- The percentage of patients achieving a >=50% reduction in MMD was lower after treatment was reinitiated: 49.0% at Month 1 and 58.9% at Month 3 before cessation, versus 35.7% at Month 1 and 45.5% at Month 3 after reinitiation.

Professor Dimos Mitsikostas from the National and Kapodistrian University of Athens highlighted that these findings are crucial for clinicians managing episodic and chronic migraine. He emphasized the importance of a personalized treatment approach over a standardized one, given that cessation and reinitiation can disrupt the progress in managing migraines.

Current guidelines from leading headache societies provide recommendations for starting and escalating migraine prophylactic treatments but lack robust evidence for discontinuing therapy. The European Headache Federation (EHF) advises considering a pause in treatment after 12-18 months, but it also recommends continuing treatment as long as necessary. Literature reviews suggest ceasing CGRP-pathway mAbs prophylaxis when there is no longer a significant need for migraine prevention, indicated by fewer than four MMDs. However, varying reimbursement policies across Europe contribute to inconsistencies, with some countries mandating a one-year pause despite limited supporting evidence.

Pinar Kokturk, M.D., Vice President & Head of Medical Affairs Europe at Teva, remarked that the new sub-analysis could challenge the rationale behind mandatory treatment pauses. She noted that the PEARL study underscores the long-term effectiveness and safety of fremanezumab in real-world settings, advocating for treatment continuity and individualized management strategies for patients.

AJOVY (fremanezumab-vfrm) is aimed at preventing migraines in adults who experience at least four migraine days per month. It is available as a 225 mg/1.5 mL injection in a pre-filled syringe or pen, with two dosing options: 225 mg once monthly or 675 mg every three months. AJOVY can be administered by a healthcare professional or at home by the patient or a caregiver, and no starting dose is required.

Teva Pharmaceutical Industries Ltd. is a global leader in pharmaceuticals with over 120 years of experience. The company leverages its extensive generics expertise and innovative approaches to improve health outcomes for millions of patients worldwide, supported by a workforce of approximately 37,000 employees across 58 markets.