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

Safety and tolerability of fremanezumab for treating migraine: where are we now? (PubMed, Expert Opin Drug Saf) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Teva has announced positive results from the phase 4 PEARL study of AJOVY (fremanezumab), its treatment for chronic (CM) and episodic migraine (EM). (Pharmafile) - "Results from the study showed that primary and secondary endpoints had been met: over 66% of EM patients achieved a 50% reduction in monthly migraine days (MMD) during the first six months of treatment, as did 51.6% of CM patients. AJOVY also demonstrated sustained migraine prevention over the course of the 24 months."

P4 data • Migraine

Prescription of Monoclonal Antibodies Against Calcitonin Gene-Related Peptide for the Prophylaxis of Migraine in Austria: A Retrospective, Longitudinal Analysis of Nationwide Insurance Data. (PubMed, Eur J Neurol) - "In this nationwide study persistence with CGRP-mAbs was excellent; dispensations of triptans and other preventatives decreased during CGRP-mAb therapy. Therapy breaks were common, but the majority resumed CGRP-mAbs, which indicates the need for long-term prophylaxis."

Journal • Reimbursement • Retrospective data • US reimbursement • CNS Disorders • Migraine • Pain

A retrospective audit of the real-world safety and effectiveness profile of eptinezumab for treatment-resistant chronic migraine in Australia. (PubMed, Headache) - "Our findings show that eptinezumab is a safe, well-tolerated migraine prophylactic that decreases monthly migraine and headache days in a small sample of Australian patients with treatment-resistant chronic migraine. Further prospective studies with larger sample sizes and longer follow-up data are needed to confirm findings of this study."

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

Is there an association between the effectiveness of anti-CGRP monoclonal antibodies in migraine and injection site reactions? (EHF-EHC 2025) - "The cohort included patients receiving erenumab (24.8%), galcanezumab (27.8%) and fremanezumab (47.4%). However, our findings suggest that the presence of these reactions does not compromise the clinical efficacy of the treatment. While ISRs may cause patient discomfort, they do not appear to influence therapeutic outcomes."

CNS Disorders • Dermatology • Migraine • Pain

Effectiveness and tolerability of anti-CGRP monoclonal antibodies for the prevention of migraine in pediatric patients in real world (EHF-EHC 2025) - "Types of mAbs: erenumab 140 mg (50.0%), fremanezumab 125 mg (30.0%), galcanezumab 120 mg (20.0%). Anti-CGRP mAbs in adolescents with resistant migraine in real world are well tolerated, with effectiveness similar to that observed in the adult population during the first 3 months of treatment. Our data support the use of anti-CGRP mAbs as a therapeutic option in the pediatric population."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine • Pain • Pediatrics

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 (EHF-EHC 2025) - P3 | "The primary endpoint was not met in the CM study; further evaluation in this population is ongoing. Fremanezumab demonstrated favorable safety and tolerability profiles in both studies, consistent with those observed in pivotal adult trials."

Clinical • P3 data • CNS Disorders • Migraine • Pain

Long-term efficacy and predictors of response of cgrp monoclonal antibodies in migraine prevention: A real-world service evaluation (EHF-EHC 2025) - "Most first received fremanezumab ( n =157, 70%) or erenumab ( n =65, 29%); one received galcanezumab. Response is more likely in triptan responders and those starting later. Poorer outcomes with longer migraine duration, more premonitory symptoms, and prior failure of preventives support early initiation of mAbs for a better outcome."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine • Pain

People with migraine and two years treatment with anti-CGRP therapies. First results from the prospective national registry "Hercules" (EHF-EHC 2025) - "So far, 322 subjects with migraine and prior failure to at least 3 repurposed anti-migraine prophylactic treatments attending 7 headache centers in Greece have been recorded, of whom 141 (43.7%) completed the 2-year treatment with anti-CGRP agents [17/141 (12%) subjects with erenumab; 18/141 (12.7%) with galcanezumab; and 106/141 (75.2%) with fremanezumab] while 51/322 (15.8%) participants discontinued treatment [fremanezumab 26/322 (8%); galcanezumab 17/322 (5.3%); 7/322 (2.2%) erenumab; eptinezumab 1/322 (0.3%)], due to failure [40/322 (12.4%)], adverse events (AE) [9/322 (2.8%)], or complete remission of migraine [2/51 (0.6%)]. More than 75% or 100% reduction in MMDs were recorderd in 38/141 (26.9%) and 9/141 (6.4%) subjects. Anti-CGRP mAbs are effective, safe, and well tolerated after long-term administration and should be considered as a first-line prophylactic treatment for migraine."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Four‑year real‑world efficacy and tolerability of anti‑CGRP therapies in a tertiary headache centre in England (EHF-EHC 2025) - "A total of 548 treatments were initiated in 415 patients (rimegepant: n=57; atogepant: n=60; erenumab: n=283; fremanezumab: n=136; galcanezumab: n=12). Atogepant was associated with the most adverse effects, with constipation, dizziness, and "brain fog" reported. Fremanezumab was associated with a higher treatment success rate than erenumab, rimegepant, and atogepant in our cohort."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Satisfaction rates and self-reported adverse events of antiCGRP therapies for migraine prevention – Focus on patient perspectives (EHF-EHC 2025) - "4% of questionnaires corresponded to patients on Atogepant, 9.3% on Erenumab , 24.4% on Eptinezumab, 29% on Galcanezumab and 32% on Fremanezumab. Most frequent, were gastrointestinal symptoms and local skin reactions. Nevertheless, some other complaints were not expected such as weight gain, dizziness, palpitations and chest pain arising in more than 10% of patients, showing the need for maintaning recent therapies adverse events surveillance"

Adverse events • Clinical • Cardiovascular • CNS Disorders • Hypertension • Migraine • Pain

Migraine prevention with Fremanezumab: Efficacy assessment (EHF-EHC 2025) - "FRM demonstrares sustained long-term efficacy and significant clinical benefits, including in patients with comorbidities like depression and medication overuse. Its innovative mechanisms and favorable pharmacokinetics make it a promising option for migraine prevention."

Clinical • CNS Disorders • Depression • Liver Failure • Migraine • Nephrology • Pain • Renal Disease

Chronology of response to Anti-CGRP mAbs in migraine: The CRONOS-CGRP study (EHF-EHC 2025) - "We conducted a single-center prospective cohort study including 462 patients with episodic or chronic migraine treated with erenumab, galcanezumab, or fremanezumab between February 2021 and November 2024. Switching may be most beneficial around month 4 in non-responders. Baseline clinical features may help predict early response."

CNS Disorders • Migraine • Pain

Short-term longitudinal white matter structural changes in patients with migraine with 12-week positive response to fremanezumab (EHF-EHC 2025) - "Representative examples are shown in Figure 1, including the complete list of diffusion descriptors. For the whole group of patients and baseline CM, longitudinal changes were only identified with FW-DTI and MISFIT, with the same trend as for patients with HFEM.Fremanezumab causes short-term localized white matter longitudinal changes in patients with migraine with positive response."

Clinical • CNS Disorders • Migraine • Pain

Early efficacy of fremanezumab in children and adolescents with episodic migraine (EHF-EHC 2025) - P3 | "2 LS mean change from baseline in average WMD at Weeks 1, 2, 3, and 4 Fig. 3 LS mean change from baseline in average MHD at Months 1, 2, and 3 Compared with placebo, fremanezumab led to numerically greater reductions in MMD and MHD within 1 month of initiating treatment in children and adolescents with EM, with reductions in WMD observed by Week 1."

Clinical • CNS Disorders • Migraine • Pain

Retrospective evaluation of safety and tolerability of fremanezumab in patients with vascular risk factors (EHF-EHC 2025) - "Therefore, in our experience fremanezumab can be safe, to be used in patients with cerebrovascular risk factors. We aim to review our remaining 1000 patients to add further power to our data."

Retrospective data • Cardiovascular • Cerebral Hemorrhage • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders • Myocardial Infarction

Local cutaneous complications of CGRP monoclonal antibodies: A case series (EHF-EHC 2025) - "Nine women treated with subcutaneous anti-CGRP monoclonal antibodies developed mild/moderate local cutaneous reactions (mainly erythema, induration, edema, and pruritus) representing 5% of all treated patients (n=190; fremanezumab 88, galcanezumab 75, erenumab 27)...Two continued therapy with supportive measures (local cooling, topical corticosteroid cream, pre/post-injection antihistamines, and rotation of injection site to abdominal area), while five required switching due to persistent reactions with or without lack of efficacy: two to atogepant, one to erenumab then eptinezumab, and one directly to eptinezumab; one discontinued...Supportive measures allowed continuation in some cases, but most required switching to another monoclonal antibody or a gepant. Monitoring and proactive management are essential to minimize treatment discontinuation."

Clinical • CNS Disorders • Dermatology • Immunology • Migraine • Pruritus

Discontinuation of anti-calcitonin Gene-Related Peptide (CGRP) monoclonal Antibodies (mAbs) in migraine patients after 12 months of good response: Are there any predictors of restarting mAbs need? Real-world cohort of 103 patients (EHF-EHC 2025) - "They received fremanezumab (n=77) or galcanezumab (n=26) for a median of 25.9 months (IQR 15.6–39.7). In this real-world cohort, nearly half of the patients who discontinued anti-CGRP monoclonal antibodies after a sustained good response eventually required resuming treatment. No clinical or demographic predictors were identified, supporting individualized decisions and close follow-up."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine • Pain

Long-term effectiveness of monoclonal antibodies targeting CGRP in migraine patients (EHF-EHC 2025) - "We aim to evaluate the effectiveness of 3 anti-CGRP subcutaneous monoclonal treatments (erenumab, galcanezumab and fremanezumab) over 2 to 3 years. Monoclonal antibodies showed a remarkable decrease in the frequency of headaches and migraine, as well as the score in MIDAS and HIT-6 scales, not being influenced by the mentioned confusion factors. This improvement is more noticeable during the first 6 months of treatment, but is stable over time until 36 months."

Clinical • Cardiovascular • CNS Disorders • Fibromyalgia • Inflammation • Migraine • Musculoskeletal Pain • Pain • Rheumatology

CGRP, VIP and PACAP plasmatic levels in migraine patients before and after anti-CGRP(R) monoclonal antibodies prophylaxis (EHF-EHC 2025) - "From Feb 2022 to Feb 2023, we enrolled 56 migraineurs who began prophylaxis with erenumab (n=26), galcanezumab (n=16), or fremanezumab (n=14). VIP and PACAP levels remained unaffected by treatment. Further studies are needed to clarify their interplay with CGRP in migraine pathogenesis."

Clinical • CNS Disorders • Migraine • Pain • ADCYAP1

Neurophysiological correlates of Anti-CGRP therapy response in chronic migraine: A pilot study using quantitative sensory testing and conditioned pain modulation (EHF-EHC 2025) - "This pilot prospective cohort study enrolled women with chronic migraine under anti-CGRP monoclonal antibody therapy (fremanezumab)...However, only at 6-months follow-up were modest improvements observed in pressure and mechanical thresholds as well as in descending pain inhibition. These findings support further investigation into personalized approaches to migraine treatment based on neurophysiological profiling."

Clinical • CNS Disorders • Migraine • Pain

Does Fibromyalgia improve with CGRP targeting therapy? (EHF-EHC 2025) - "The most commonly used CGRP monoclonal antibody was fremanezumab (63%), followed by erenumab (30%) and galcanezumab (7%). Our study showed that a minority of patients with migraine and fibromyalgia will experience improvement in their fibromyalgia symptoms with CGRP mAbs. This may suggest the underlying biology of fibromyalgia in patients with migraine is largely driven by mechanisms other than CGRP."

CNS Disorders • Fibromyalgia • Migraine • Musculoskeletal Pain • Otorhinolaryngology • Pain • Rheumatology • Vertigo

Eptinezumab for migraine prevention: Initial experience from a Portuguese tertiary hospital (EHF-EHC 2025) - "Prior anti-CGRP monoclonal antibody use was documented in 14 patients (78%), all of whom had previously received galcanezumab. Among them, 4 were also treated with fremanezumab, and 1 of these had additionally received erenumab...Nonetheless, in this cohort, it was not frequently selected as a first-line option, being primarily used in patients with highly refractory migraine. Treatment adherence was high and further data are needed to assess long-term effectiveness and better define its role in clinical practice."

Clinical • CNS Disorders • Migraine • Pain

COACT study: CGRPmAbs + OnabotulinumtoxinA assessment of chronic migraine treatments study (EHF-EHC 2025) - "To evaluate the safety and efficacy of combination therapy with the calcitonin gene-related peptide monoclonal antibody (CGRP mAb) fremanezumab and onabotulinumtoxinA in patients with chronic migraine (CM) who were previously treated with a stable dose of onabotulinumtoxinA. Significant reductions in HIT-6 scores at 12 weeks and 24 weeks were also seen. These findings support the use of CGRP mAbs and onabotulinumtoxinA for the preventive treatment of chronic migraine."

CNS Disorders • Migraine • Pain

Reporting of lack of efficacy of anti-CGRP monoclonal antibodies in migraine patients treated with other concomitant monoclonal antibodies: A VigiBase disproportionality analysis (EHF-EHC 2025) - "Reports listing erenumab, galcanezumab, fremanezumab, or eptinezumab as suspected or interacting drugs and collected in VigiBase up to March 9th, 2025 were included and classified as cases (reporting lack of efficacy) or non-cases (reporting other adverse drug reactions). The concomitant use of other mAbs in patients receiving anti-CGRP mAbs for migraine is not associated with increased reporting of lack of efficacy in VigiBase. These findings offer preliminary reassurance regarding the real-world effectiveness of anti-CGRP mAbs when administered in combinations with mAbs for other indications."

Clinical • CNS Disorders • Migraine • Pain