Core Insights - Teva Pharmaceutical Industries Ltd. announced the final analysis of the PEARL Phase 4 migraine prevention study, demonstrating that AJOVY (fremanezumab) showed sustained effectiveness over a two-year period in reducing migraine frequency, duration, and severity [1][3] Study Overview - The PEARL study was a 24-month real-world observational study involving 1,140 patients, predominantly female (87.25%), with 33.1% having episodic migraine (EM) and 66.9% chronic migraine (CM) [2][3] - The primary endpoint was a ≥50% reduction in Monthly Migraine Days (MMD) during the first 6 months of treatment, with secondary endpoints including mean change from baseline in MMD and treatment adherence [2] Effectiveness and Adherence - Over 66% of patients with EM and 51.6% with CM achieved the primary endpoint and benefitted from sustained migraine prevention for over 24 months [1][3] - Injection adherence rates remained high at approximately 90%, with over 75% (854 out of 1,129) of participants completing the study duration [1][3] Safety and Tolerability - The final analysis confirmed the favorable long-term safety and tolerability of fremanezumab, consistent with its known safety profile from previous studies [1][3] - The data supports the continued clinical use of fremanezumab for migraine prevention, particularly in populations with high disease impact [1][3] Clinical Implications - The findings underscore the importance of real-world studies in shaping clinical practice and highlight the critical role of CGRP-pathway therapies in improving patient outcomes, especially given that migraine is the second leading cause of disability worldwide [1][3]

Core Insights - AbbVie announced positive topline results from its Phase 3 TEMPLE study, demonstrating that atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) is more tolerable and effective than topiramate for migraine prevention in adults with a history of four or more migraine days per month [1][4][5] Group 1: Study Results - The study met its primary endpoint, showing a significantly lower discontinuation rate due to adverse events (AEs) with atogepant (12.1%) compared to topiramate (29.6%), resulting in a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001) [1][4][6] - All six secondary endpoints were met, with 64.1% of patients on atogepant achieving a ≥50% reduction in mean monthly migraine days during months 4 to 6, compared to 39.3% for topiramate (p<0.0001) [1][4][5] Group 2: Study Design - The TEMPLE study was a Phase 3, multicenter, randomized, double-blind, active-controlled trial involving 545 participants aged 18 and older across 73 sites in Europe, Israel, and Canada [3][4] - The study included a 24-week double-blind treatment period followed by a 52-week open-label treatment period, where all participants received atogepant [5][6] Group 3: Industry Context - Migraine affects approximately 14% of the global population and is the second leading cause of disability worldwide, indicating a significant unmet need for effective preventive treatments [1][2] - Over 50% of individuals currently using preventive medications still qualify for further treatment, highlighting gaps in patient care and the need for improved therapeutic options [1][2][3]