Ajovy (fremanezumab-vfrm) / Otsuka, Teva - LARVOL DELTA

Real-World Clinical Effectiveness and Migraine-Related Healthcare Resource Utilization in Patients Initiating Fremanezumab in Germany and the United Kingdom. (PubMed, Ther Clin Risk Manag) - "Reductions in mean MIDAS and HIT-6 scores (all p < 0.01 vs baseline), outpatient office visits, urgent care/emergency room visits, and inpatient admissions were also observed (all p < 0.05 vs baseline) for both countries. Fremanezumab demonstrated real-world clinical effectiveness in German and UK cohorts and may decrease the burden of migraine for patients and providers."

HEOR • Journal • Real-world evidence • CNS Disorders • Migraine • Pain

Delayed urticaria during treatment with anti-CGRP monoclonal antibodies in migraine. (PubMed, Headache) - "Anti-CGRP mAb-associated urticaria in this case series was delayed and likely non-immunoglobulin E (non-IgE)-mediated. Our experience supports that in selected patients with delayed urticaria, individualized management, including H1 antihistamine premedication, may allow continuation of effective migraine prophylaxis. Larger cohorts are needed to identify risk factors and to inform general management recommendations."

Journal • Allergy • Cardiovascular • CNS Disorders • Dermatology • Immunology • Migraine • Pain • Urticaria

Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data. (PubMed, Headache) - "This systematic review confirms that CGRP inhibitors have a manageable yet complex safety profile. It distinguishes rare, serious cerebrovascular events (RCVS, CeAD) associated with some mAbs but not with gepants, as well as shared adverse effects such as Raynaud's phenomenon and alopecia. Significant heterogeneity in safety profiles-from erenumab's pronounced constipation SDR to zavegepant's unique dysgeusia-challenges the view of CGRP inhibitors as a monolithic category. These findings provide a clear rationale for personalized risk assessment, enabling clinicians to tailor treatment to individual patient profiles."

Journal • P4 data • Review • Alopecia • Cardiovascular • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Migraine • Pain • Rheumatology • Vascular Neurology • ROR1

Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Fremanezumab in Children and Adolescents with Migraine. (PubMed, Eur J Drug Metab Pharmacokinet) - "Finally, we discuss unresolved issues related to long-term CGRP blockade during growth, including theoretical effects on vascular regulation, bone metabolism, and neurodevelopment. Overall, fremanezumab represents a novel, mechanism-based preventive option for older children and adolescents with episodic migraine, while highlighting the need for continued longitudinal studies to define its long-term safety and optimal role in pediatric migraine management."

Journal • PK/PD data • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy • Migraine • Pain • Pediatrics

RACIAL AND ETHNIC DISPARITIES IN ADOPTION OF NOVEL CGRP THERAPIES FOR MIGRAINE PREVENTION: A RETROSPECTIVE COHORT STUDY USING THE KOMODO RESEARCH DATASET (ISPOR 2026) - "OBJECTIVES: To evaluate racial disparities in uptake of calcitonin gene-related peptide (CGRP) therapies (Erenumab, Fremanezumab, Galcanezumab, Eptinezumab, Atogepant, or Rimegepant) for migraine prevention among adults in the United States. This retrospective cohort study was conducted using the Komodo Research Dataset and Komodo Race and Ethnicity. CGRP initiation remained low across all groups. Although median time to initiation was similar, cumulative incidence patterns suggest differential adoption over time."

Retrospective data • CNS Disorders • Migraine • Pain

COMPARING THE DISEASE BURDEN OF MIGRAINE BETWEEN USERS OF CGRP MONOCLONAL ANTIBODIES AND PREVENTIVE GEPANTS (ISPOR 2026) - "Analysis included participants that: (1) Experienced migraine or migraine headaches in the past 12 months; (2) Physician diagnosis of migraine; and (3) Currently using CGRP mAbs (erenumab, fremanezumab, eptinezumab, or galcanexumab) or preventive gepants (rimegepant or atogepant). In a national survey of general US adults, CGRP mAbs users reported fewer migraines and headache days than those on preventive gepants (though still greater than the meaningful clinical goal of ≤4 days per month), but experienced lower treatment efficacy, greater mental health burden and migraine-related disability. These findings underscore the need to address psychological and functional burden among patients on migraine preventives."

CNS Disorders • Depression • Migraine • Mood Disorders • Pain

TITLE: COST-UTILITY ANALYSIS OF CALCITONIN GENE-RELATED PEPTIDE ANTIBODIES FOR PATIENTS WITH CHRONIC MIGRAINE: A UNITED STATES PAYER PERSPECTIVE (ISPOR 2026) - "At current prices, CGRP monoclonal antibodies were not cost-effective compared with best supportive care from a U.S. payer perspective. These findings may inform payer decision-making regarding coverage and reimbursement for chronic migraine prevention."

Clinical • HEOR • CNS Disorders • Migraine • Pain

Risk Stratification of Hypertension Induced by CGRP Antagonist in Migraine Treatment: A Retrospective Observational Analysis (AAN 2026) - "With the growing use of the Gpant class of drugs and other CGRP inhibitors in clinical settings, it is critical to determine which populations are most at risk for developing this side effect.Design/ 250 patients prescribed any CGRP antagonist, including erenumab, fremanezumab, galcanezumab, eptinezumab, and the gepants (ubrogepant, rimegepant, atogepant, zavegepant).Variables extracted included: age at start, sex, and body mass index (BMI). Hypertension following CGRP initiation is an early event, occurring within the first few months.Once developed, hypertension tends to persist, with no new cases after 3 months. The pattern is similar across drug classes, indicating that risk is likely related to the CGRP pathway blockade rather than a specific molecule."

Retrospective data • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Diabetes • Hypertension • Metabolic Disorders • Migraine • Nephrology • Obstructive Sleep Apnea • Pain • Renal Disease • Respiratory Diseases • Sleep Disorder

Sleep and anti-calcitonin gene related (CGRP) drugs: current evidence and perspectives. (PubMed, Sleep Med Rev) - "Although results are inconsistent across instruments, emerging data suggest that anti-CGRP mAbs and gepants, particularly erenumab, galcanezumab, and atogepant, can improve subjective sleep quality and objective measures such as sleep efficiency in some cases. Evidence for fremanezumab and eptinezumab remains scarce, whereas large-scale pharmacovigilance datasets indicate low rates of insomnia, somnolence, or abnormal dreams. Overall, current findings suggest that CGRP inhibition impacts the sleep system, but the mechanisms of this interaction remain partly understood, representing a promising area for mechanistic exploration and clinical application. Future studies with standardized sleep endpoints are needed to distinguish direct neuropharmacological effects from indirect benefits mediated by improvement in migraine burden."

Journal • Review • CNS Disorders • Insomnia • Migraine • Pain • Sleep Disorder

A Real-World Study of CGRP Monoclonal Antibodies for Migraine: Long-Term Effectiveness and Treatment Adherence. (PubMed, Eur J Neurol) - "CGRP mAbs were associated with a long-term reduction in migraine frequency and favorable tolerability."

Journal • Observational data • Real-world evidence • Retrospective data • CNS Disorders • Mental Retardation • Migraine • Pain • Psychiatry

Comparative Efficacy and Safety of CGRP Monoclonal Antibodies and Oral Gepants for Migraine Prevention: Evidence from Randomized Controlled Trials and Network Meta-analysis (AAN 2026) - "Treatments included erenumab (n = 3,276), fremanezumab (n = 2,481), galcanezumab (n = 2,348), eptinezumab (n = 1,912), and atogepant (n = 1,196). CGRP monoclonal antibodies and oral gepants demonstrated consistent, durable efficacy and excellent safety for migraine prevention, with overall low risk of bias across included trials."

Retrospective data • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

CGRP Monoclonal Antibodies vs Gepants: Risk of Vascular Outcomes: A TriNetX Multicenter Electronic Medical Record Analysis (AAN 2026) - "Real-world evidence comparing vascular risk between mAbs and gepants remains limited.Design/ We conducted a cross-sectional study using the TriNetX® database to identify adults with migraine (ICD-10 G43) prescribed CGRP mAbs (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (atogepant, rimegepant). CGRP mAbs were linked to greater vascular risk than gepants. Elevated risk among never-users may reflect underlying clinical characteristics, prescribing patterns, and possibly a protective effect of CGRP inhibitors. These findings stress the need for prospective studies to clarify causality and guide vascular safety monitoring."

Clinical • Cardiovascular • CNS Disorders • Hypertension • Migraine

Efficacy and Safety of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Children and Adolescents: Outcomes from Two Randomized, Double-blind, Placebo-controlled, Phase 3 Studies (AAN 2026) - P3 | "Treatment with fremanezumab led to statistically significant reductions in MMD and MHD in children and adolescents with EM, but not in children and adolescents with CM. Safety findings were consistent with those observed in pivotal adult trials."

Clinical • P3 data • CNS Disorders • Migraine • Pain

Impact of Early Fremanezumab Initiation and Treatment Pauses on the Reduction of Monthly Migraine Days: Analyses from the PEARL Study (AAN 2026) - "These analyses suggest that optimal treatment efficacy occurs when fremanezumab is initiated early, prior to failure of multiple other preventive treatments, and is sustained without interruption."

CNS Disorders • Migraine • Pain

Treatment with Fremanezumab Attenuates the Association Between Weather and Headache in Participants with Episodic Migraine: A Post Hoc Analysis of the HALO-EM and HALO-LTS Studies (AAN 2026) - "Fremanezumab attenuated the association between a 10 F increase in temperature and AOH or NOH days, suggesting that long-term fremanezumab treatment may prevent temperature-triggered headaches in people with EM."

Retrospective data • CNS Disorders • Migraine • Pain

Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45 (clinicaltrials.gov) - P4 | N=72 | Active, not recruiting | Sponsor: Brigham and Women's Hospital | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2026 ➔ Jul 2026

Enrollment closed • Trial primary completion date • CNS Disorders • Migraine • Pain

Identifying cardiac safety signals of disproportionate reporting for CGRP antagonists: evidence from the FDA Adverse Event Reporting System. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "CGRP antagonists included monoclonal antibodies (erenumab, fremanezumab, galcanezumab, eptinezumab) and small-molecule receptor antagonists (rimegepant, ubrogepant, atogepant). These results are hypothesis-generating and reflect reporting patterns rather than incidence or relative risk; therefore, they should not be interpreted as evidence of causality or as patient-level cAE risk factors. Continued post-marketing surveillance and confirmatory pharmacoepidemiologic studies in well-defined populations are warranted.  CLINICAL TRIAL NUMBER: Not applicable."

Adverse events • Journal • Cardiovascular • CNS Disorders • Coronary Artery Disease • Migraine • Pain

Effectiveness and safety of anti-CGRP monoclonal antibodies in hemiplegic migraine: an individual patient quantitative analysis. (PubMed, J Headache Pain) - No abstract available

Journal • Review • CNS Disorders • Migraine • Pain

Evaluating dual calcitonin gene-related peptide antagonists for chronic migraine prevention. (PubMed, Headache) - "Trialing two preventive CGRP antagonists may be an effective approach for some patients with chronic migraine who have exhausted other preventive treatment options, with some patients in this study experiencing a significant reduction in headache frequency and severity. Prospective studies with larger, more diverse populations should be completed to confirm these findings and investigate any potential stroke risks."

Journal • Cardiovascular • CNS Disorders • Ischemic stroke • Migraine • Pain

Drugs for Migraine Prophylaxis. (PubMed, Dtsch Arztebl Int) - "The new prophylactic drugs against migraine are effective, well-tolerated, and especially useful for patients for whom traditional oral migraine prophylactic drugs and onabotulinum toxin A are ineffective, not tolerated, or contraindicated."

Journal • CNS Disorders • Migraine • Pain

Teva Canada Announces Approval of Expanded Indication of [Pr] AJOVY (fremanezumab solution for subcutaneous injection), the First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine (Canada Newswire) - "Health Canada's approval of this indication is based on the results of Phase 3 SPACE trial, which demonstrated that fremanezumab significantly reduced monthly migraine days and monthly headache days versus placebo over a 12–week period in pediatric patients with episodic migraine and showed a safety profile consistent with adults."

Canada approval • Migraine

Botulinum Toxin Type A for the Prevention of Migraines: An Umbrella Review of Systematic Reviews. (PubMed, Toxins (Basel)) - "Overall, quantitative evidence indicated favorable effects of BoNT-A compared with placebo for chronic migraines, across headache frequency, headache severity, and acute medication use, but less efficacy than topiramate and the CGRP monoclonal antibodies (CGRPmAbs) galcanezumab and fremanezumab. Although botulinum toxin type A is widely used as a preventive treatment for chronic migraines, the available evidence supports its efficacy at a moderate level. Further head-to-head and long-term analyses are needed to clarify its comparative role alongside newer biologic treatments."

Journal • Review • CNS Disorders • Migraine • Pain

Ajovy: "Reduction of ≥50% in number of migraine days per month”; Migraine (Teva) - Q4 & FY 2025 Results

P3 data • Migraine

Fremanezumab, Migraine and Sleep (clinicaltrials.gov) - P4 | N=22 | Terminated | Sponsor: Beth Israel Deaconess Medical Center | N=100 ➔ 22 | Recruiting ➔ Terminated; We could not recruit enough patients who fulfilled inclusion criteria and eventually gave up and terminated the study. The reason for not closing it is that we did have

Enrollment change • Trial termination • CNS Disorders • Migraine • Pain • Sleep Disorder

Real-World Insights into Dual Calcitonin Gene-Related Peptide (CGRP) Therapies for Chronic Migraine: A Retrospective Review. (PubMed, Pain Physician) - "Dual-CGRP regimens may enhance migraine symptom control by reducing headache severity without causing significant adverse events. However, these findings need confirmation through randomized, placebo-controlled clinical trials that use larger sample sizes."

Clinical • Journal • Real-world evidence • Retrospective data • CNS Disorders • Migraine • Pain