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

Prevention of Episodic Migraine in Children: Is Fremanezumab Safe and Effective? (Neurology Advisor) - P3 | N=235 | SPACE (NCT04458857) | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | "Fremanezumab is effective and safe for the treatment of pediatric episodic migraine, according to study results presented at the 2025 American Academy of Neurology (AAN) annual meeting...To assess the safety and efficacy of fremanezumab in the pediatric setting, researchers conducted the phase 3, randomized, double-blind, placebo-controlled trial SPACE...During the 12-week treatment period, fremanezumab reduced MMD by a least-squares mean difference (LSMD) of 2.5 days compared with 1.4 days with placebo (P =.0210)...Stratified by age, fremanezumab was favored over placebo for reducing MMD among children aged 6 to 11 years (LSMD, -3.4 vs -1.7 days) and 12 to 17 years (LSMD, -2.7 vs -1.8 days), respectively....Fremanezumab was also associated with a greater reduction in MMD relative to placebo among boys (LSMD, -3.5 vs -2.2 days) and girls (LSMD, -2.3 vs -1.5 days), respectively."

P3 data • Migraine

Migraine treatment with CGRP monoclonal antibodies: patient evaluation of a mandatory treatment holiday in Belgium. (PubMed, Acta Neurol Belg) - "A rigid, mandatory treatment holiday of two to three months poses significant challenges for a substantial subset of patients, leading to rapid migraine deterioration and increased anxiety. The observed association between migraine deterioration and anxiety highlights the need for patient education strategies. Policy makers should consider these findings to develop more flexible, patient-centered treatment approaches that optimize outcomes."

Journal • CNS Disorders • Migraine • Mood Disorders • Pain • Psychiatry

Predictors of Response to Treatment With Anti-calcitonin Gene-Related Peptide (CGRP) Antibodies in Real-World Patients With Episodic Migraine: A Two- and Four-Month Prospective Study. (PubMed, Cureus) - "Normal BMI was found to be significantly associated with a reduction in migraine frequency of >50%, whereas normal BMI, unilateral headache, and severe osmophobia were significantly associated with a mean MHD reduction. Further controlled studies with several other factors predicting response to anti-CGRP mAbs are warranted."

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

Dual biological treatments in immune-mediated disorders: a single center experience. (PubMed, BMC Immunol) - "Dual biological treatment with omalizumab and another biologic appears to be safe, with no need to discontinue non-IgE-targeting agents during omalizumab therapy."

Journal • Retrospective data • Asthma • Chronic Spontaneous Urticaria • Dermatology • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Urticaria • IL17A • IL4 • IL5

A National Cross-Sectional Survey on Real-World Experiences of Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody Use in Adults with Migraine in Finland. (PubMed, Pain Ther) - "Patient experiences of using subcutaneous CGRP mAbs in Finland showed improvements in several migraine-related factors, supporting the potential for CGRP mAbs to improve the quality of life of adults with migraine."

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

Teva Announces FDA Filing Acceptance for AJOVY (fremanezumab) in Pediatric Episodic Migraine Prevention (Teva Press Release) - "Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd...announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more....The application was based on positive results from the Phase 3 SPACE trial, which evaluated the efficacy and safety of AJOVY for the prevention of episodic migraine in pediatric patients."

FDA filing • Migraine

Health care resource utilization and direct costs incurred over 12 months by patients with migraine initiating self-injectable calcitonin gene-related peptide monoclonal antibodies: A US real-world study. (PubMed, J Manag Care Spec Pharm) - "HCRU and direct cost differences observed at 12 months following initiation of self-injectable CGRP mAbs for migraine prevention were numerically similar across cohorts for patients treated with galcanezumab, fremanezumab, and erenumab. More work should be done to learn if these drugs perform differently with respect to other important factors not examined here."

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

Patient satisfaction with calcitonin gene-related peptide monoclonal antibodies in migraine: A multicenter prospective cohort study. (PubMed, Headache) - "Most patients were satisfied with CGRP mAbs' effectiveness, tolerability, and convenience in a real-world setting. Interestingly, increasing TS was associated with meaningful reductions in frequency, impact, and disability caused by migraine."

Journal • CNS Disorders • Migraine • Pain

CROATIAN GUIDELINES FOR SPECIFIC PREVENTIVE TREATMENT OF MIGRAINE WITH MONOCLONAL ANTIBODIES TARGETING CALCITONIN GENE-RELATED PEPTIDE (CGRP) (EPTINEZUMAB, FREMANEZUMAB, AND GALCANEZUMAB) OR THE CGRP RECEPTOR (ERENUMAB). (PubMed, Acta Clin Croat) - "These medications may be considered as first-line prophylactic therapy depending on the patient's history, concomitant diseases, and disease burden. Further real-world studies are needed to elucidate other aspects of their application."

Clinical guideline • Journal • Review • CNS Disorders • Inflammation • Migraine • Pain

Long-term efficacy of 675-mg Fremanezumab on Chronic, Episodic, and Medication-Overuse Headaches (JSNE 2025) - No abstract available

Clinical • Pain

Fremanezumab for the Treatment of Migraine Complicated by Medication Overuse: A Systematic Review. (PubMed, Clin Drug Investig) - "Both post hoc analyses from clinical trials and real-world studies support fremanezumab benefits in reducing migraine frequency, medication use, and headache-related disability in adults with migraine complicated by medication overuse. Given the limited quality of data, further real-world research with standardized reporting criteria is needed to substantiate long-term benefits and establish optimal treatment protocols."

Journal • Review • CNS Disorders • Migraine • Pain

Efficacy and continuability of 675 mg fremanezumab administration over 2 years. (PubMed, J Headache Pain) - "Fremanezumab 675 mg quarterly dose effectively reduces headache frequency over an extended period and may facilitate medication cessation in patients who experience substantial recovery."

Journal • Observational data • CNS Disorders • Dermatology • Migraine • Pain

The Safety and Effectiveness of Dual Calcitonin Gene-Related Peptide (CGRP) Therapies for Migraine Treatment: A Focus on Small Molecule Antagonist and Ligand Monoclonal Combinations (AAN 2025) - "Our study aims to assess the effects of this dual-CGRP approach.Design/A retrospective matched cohort study was conducted at a neurological care center in Hawaii, analyzing 90 chronic migraine patients aged ≥18 years treated with CGRP inhibitors (L-mAbs: fremanezumab, galcanezumab, eptinezumab; SMAs: ubrogepant, rimegepant, atogepant; or a combination)...Variables included age, age at diagnosis, sex, onabotulinumtoxinA use, headache frequency, duration, severity, and associated symptoms before and three months post-treatment...Dual-CGRP regimens may provide improved effectiveness for controlling migraine symptoms by significantly reducing headache severity and aura symptoms without significant adverse events."

Clinical • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • 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 Study (AAN 2025) - "Fremanezumab treatment attenuated the association between weather variables and AOH or NOH days, suggesting that fremanezumab may prevent weather-triggered headaches in people with EM."

Retrospective data • CNS Disorders • Migraine • Pain

Comparison of different treatment strategies for medication overuse headache: a systematic review and meta-analysis (AAN 2025) - "A total of 10 randomized controlled trials and 3925 patients were included, of whom 2786 (70,98%) received monoclonal antibodies and 562 (14,3%) received botulinum toxin A, including erenumab, fremanezumab, and eptinezumab for both MOH and migraine treatments. In this meta-analysis, we concluded that both monoclonal antibodies and botulinum toxin A injections effectively achieved monthly headache and monthly migraine reductions."

Retrospective data • Review • CNS Disorders • Migraine • Pain

Long-Term Efficacy of Fremanezumab in Patients with Chronic Migraine: a Systematic Review and Single-Arm Meta-Analysis (AAN 2025) - "Fremanezumab demonstrated sustained long-term efficacy in reducing both the frequency of migraine episodes and the use of analgesics in patients with chronic migraine. These findings support the favorable safety and efficacy profile of fremanezumab for long-term use. However, further well-designed, large-scale studies are necessary to strengthen these conclusions."

Retrospective data • Review • CNS Disorders • Migraine • Pain

Real-World Long-Term Effectiveness of Fremanezumab in Patients With Migraine Who Switched From Another mAb Targeting the CGRP Pathway – Subgroup Analysis of the FINESSE Full Analysis (AAN 2025) - "Overall, 37.3% of patients in this subgroup analysis achieved an MMD reduction of ≥50% within 6 months post-fremanezumab initiation. Clinically meaningful reductions in MMD, migraine and headache-related disability, and acute medication use were demonstrated over the entire 24-month treatment period. For patients experiencing inadequate effectiveness or poor tolerability with other CGRP pathway mAbs, switching to fremanezumab may be a sustained, effective treatment option."

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

Efficacy and Safety of Fremanezumab for the Preventive Treatment of Episodic Migraine in Children and Adolescents: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (AAN 2025) - P3 | "These findings demonstrate the efficacy, safety, and tolerability of fremanezumab in children and adolescents with EM."

Clinical • P3 data • CNS Disorders • Migraine • Pain

Ajovy: Expiry of patents in US/EU in 2026 (Teva) - Annual Report 2024: Term extension in EU/US until 2031; Expiry of patents related to use for the treatment of migraine in US between 2035 and 2039

Patent • CNS Disorders • Migraine

Real-World Lessons with Fremanezumab as the Third Available CGRP Monoclonal Antibody in a Third-Level Hospital: Focus on the Factors Predicting Response. (PubMed, J Clin Med) - "Totals of 17 and 26 patients had been treated at least with galcanezumab or erenumab. The main factors associated with a lack of response were almost daily/daily headaches and a disease duration > 6 years. Half of the patients who failed to respond to erenumab improved on fremanezumab, making it sensible to switch to a treatment with a different mechanism of action, but trying a third anti-CGRP treatment in patients with no response to both a receptor-targeted and a ligand-targeted CGRP antibody hardly seems justifiable from our experience."

Journal • Real-world evidence • CNS Disorders • Depression • Fibromyalgia • Migraine • Mood Disorders • Musculoskeletal Pain • Pain • Psychiatry • Rheumatology

Review: An Update on CGRP Monoclonal Antibodies for the Preventive Treatment of Episodic Migraine. (PubMed, Curr Pain Headache Rep) - "Erenumab (AMG334), fremanezumab (TEV48125), and galcanezumab (LY2951742) are monthly subcutaneous injections, while eptinezumab (ALD403) provides an intravenous infusion option. These investigations have built evidence for earlier access to CGRP treatment as they increase quality of life and reduce monthly migraine days while being better tolerated than non-specific migraine preventative therapies. These studies support the recent 2024 AHS consensus statement recommending CGRP monoclonal antibodies be considered as first-line preventive treatment in episodic migraine."

Journal • Review • CNS Disorders • Migraine • Pain

Health Technology Assessment: Evaluation of 8 CGRP-Targeted Therapy Drugs for the Treatment of Migraine. (PubMed, Drug Des Devel Ther) - "The final assessment result scores from highest to lowest were rimegepant (84.5 points), erenumab (75.78 points), galcanezumab (74.02 points), fremanezumab (73.93 points), atogepant (72.64 points), eptinezumab (71.69 points), ubrogepant (70.37 points), zavegepant (56.44 points). Rimegepant, erenumab, fremanezumab, atogepant, galcanezumab, eptinezumab, ubrogepant can be entered into the medication list of medical institutions as strongly recommended drugs."

Journal • Review • CNS Disorders • Migraine • Pain

The anti-CGRP mAb Fremanezumab reverts the anti-inflammatory effects of CGRP in vitro but does not alter disease evolution in a mouse model of progressive multiple sclerosis. (PubMed, Eur J Pharmacol) - "Notably, we also demonstrated the ability of fremanezumab to reach the site of neurodegeneration, showing its presence in the spinal cord. Data indicate that CGRP has an irrelevant immunosuppressant effect in the complex pathophysiological scenario of MS, and suggest that the use of anti-CGRP antibodies for migraine treatment in MS patients is safe."

Journal • Preclinical • CNS Disorders • Immunology • Migraine • Multiple Sclerosis • Pain

The effect of calcitonin gene-related peptide monoclonal antibodies on restless legs syndrome in patients with migraine. (PubMed, J Headache Pain) - "Our study revealed that 3-month CGRP mAb treatment significantly alleviated RLS symptoms, central sensitization and headache-related disability in patients with comorbid migraine and RLS."

Journal • CNS Disorders • Migraine • Movement Disorders • Pain • Restless Legs Syndrome • Sleep Disorder

Physical activity as a predictor of fremanezumab response in chronic migraine - the Phy-Fre-Mig study. (PubMed, J Headache Pain) - "Patients who spent more time walking before starting treatment, were more likely to have a response to fremanezumab. PA and TS levels changed since the first month and correlated with clinical variables."

Journal • Observational data • CNS Disorders • Migraine • Pain