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

Postmarketing safety of migraine prophylactic monoclonal antibodies: An EudraVigilance database analysis of eptinezumab, fremanezumab, galcanezumab, and erenumab. (PubMed, Headache) - "Almost all of the most reported and statistically significant adverse events were nonserious and consistent with the existing literature. Given the chronic nature of migraine treatment, continuous pharmacovigilance monitoring is essential to ensure their constant safe use in clinical practice."

Journal • P4 data • CNS Disorders • Dermatology • Fatigue • Migraine • Pain

Assessment of Pharmacokinetic and Pharmacodynamic Drug-Drug Interactions with Nipocalimab and Relevance to Patients with Rheumatic Diseases (EULAR 2025) - "When used together with etanercept in patients with RA, nipocalimab may increase the clearance of etanercept via non-specific pinocytosis and blockade of FcRn and other mechanisms such as target mediated drug disposition or immunogenicity-mediated clearance, etc.[2] In addition, hydroxychloroquine (HCQ) is an immunosuppressive therapy often used in rheumatic diseases such as Sjögren’s disease (SjD), systemic lupus erythematosus (SLE), and RA, may raise the lysosomal pH[3] which may have the potential to impact the degradation of IgG, and thus may blunt the IgG lowering effect of nipocalimab, thereby causing a pharmacodynamic (PD) DDI. Decreases in PK exposure for both fremanezumab and etanercept with co-administration of nipocalimab were observed. There was a lack of HCQ impact on nipocalimab’s PD effect. There was no impact of fremanezumab, etanercept, or HCQ on nipocalimab PK in both studies."

Clinical • PK/PD data • CNS Disorders • Inflammatory Arthritis • Lupus • Migraine • Oncology • Pain • Rheumatoid Arthritis • Rheumatology • Sjogren's Syndrome • Systemic Lupus Erythematosus • TNFA

Teva Reaffirms “Pivot to Growth” Strategy Progress with Launch of Acceleration Phase at 2025 Innovation and Strategy Day (Teva Press Release) - "AUSTEDO: Expected to exceed $2.5 billion in sales by 2027 and exceed $3 billion by 2030. AJOVY: A globally established brand with presence across 43 countries and expected launches in 3 additional countries this year....duvakitug (anti-TL1A): A potentially best-in-class treatment for inflammatory bowel disease, with potential expansion into additional indications with peak sales potential of up to $2-$5 billion. DARI: A dual-action rescue inhaler for asthma, that could address a significant unmet need as a first ICS/SABA combination for both adult and pediatric patient populations, with peak sales potential of ~$1 billion....emrusolmin: A potential first-in-class treatment for Multiple System Atrophy (MSA), a rare and fatal neurodegenerative disease that currently has no approved treatments, with peak sales potential of more than $2 billion. TEV-‘408...with peak sales potential of more than $1 billion."

Launch • Sales projection • Asthma • Crohn's disease • Huntington's Disease • Inflammatory Bowel Disease • Migraine • Multiple System Atrophy

Cortical Thickness Changes in Migraine Patients Treated with Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies: A Prospective Age- and Sex-Matched Controlled Study. (PubMed, Biomedicines) - " In this prospective age- and sex-matched controlled study, 30 migraine patients receiving either anti-CGRP mAbs (fremanezumab) (n = 15) or oral preventive medications (n = 15) underwent 3T MRI scans before and after treatment... This exploratory study, based on a small sample size, suggests that cortical thickness changes may be associated with treatment response to anti-CGRP mAbs rather than with CGRP mAb treatment itself. Further studies with larger cohorts are needed to confirm these findings."

Journal • CNS Disorders • Migraine • Pain

The Effect of Fremanezumab on Pain in Patients with Complex Regional Pain Syndrome: Study Protocol of a Randomized, Double-Blind, Proof-of-Concept, Placebo-Controlled Trial. (PubMed, Brain Sci) - "Adverse events and blinding will also be assessed. If found effective, fremanezumab and other anti-CGRP antibodies may emerge as a mechanism-based treatment option for patients with CRPS, which could hopefully improve the overall care of patients with this devastating disease."

Clinical • Journal • CNS Disorders • Inflammation • Migraine • Mood Disorders • Musculoskeletal Pain • Pain

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

Clinical • Pain

Ajovy: “Global revenues of $139 million in Q1'25, +26% YoY” (Teva) - Q1 2025 Results

Commercial • Migraine

Efficacy of monoclonal antibodies against CGRP in migraine patients with fibromyalgia comorbidity: a retrospective monocentric observational study. (PubMed, J Headache Pain) - "We found that in migraine suffereres with FM, anti-CGRP monoclonal antibodies had a similar beneficial effect on migraine as in non-fibromyalgia patients, in addition to reducing somatic pain and global disability from the disease. The anti-CGRP agents, represent a good option for the treatment of migraineurs with fibromyalgia, for which no resolutive therapy is yet available."

Journal • Observational data • Retrospective data • CNS Disorders • Fibromyalgia • Migraine • Musculoskeletal Pain • Pain • Rheumatology

Teva Reports Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved (Teva Press Release) - "AUSTEDO – shows continued strong growth, with worldwide revenues of $411 million in Q1 2025, an increase of 39% in local currency terms compared to Q1 2024; increasing 2025 full-year revenue outlook from ~$1.9-2.05 billion to $1.95-2.05 billion. AJOVY – global revenues of $139 million in Q1 2025, an increase of 26% in local currency terms compared to Q1 2024. Reaffirming $600M 2025 revenue outlook. UZEDY continues strong momentum – global revenues of $39 million in Q1 2025."

Sales • CNS Disorders • Huntington's Disease • Migraine • Schizophrenia

Fremanezumab for the Treatment of Patients With Migraine and Comorbid Major Depressive Disorder: The UNITE Randomized Clinical Trial. (PubMed, JAMA Neurol) - P4 | "To the authors' knowledge, this was the first placebo-controlled, randomized clinical trial, specifically designed to assess patients with migraine and comorbid depressive disorder, to demonstrate significant improvements in migraine and depressive symptoms with a single pharmacological intervention. ClinicalTrials.gov Identifier: NCT04041284."

Clinical • Journal • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Migraine • Mood Disorders • Pain • Psychiatry

Migraine drug to reduce depressive symptoms in patients having both, finds study (The Tribune) - P=NA | N=540 | "A migraine drug has shown to significantly reduce symptoms of depression in patients—the first trial to show improvements in both the conditions using a single drug, researchers said...In the study involving 540 patients, ‘fremanezumab’ was found to reduce days of migraine in a month and symptoms of depression, compared to a placebo (inactive substance producing no effects). The drug, administered as an injection beneath the skin (subcutaneous), is available in India...The trial was conducted over a 28-week period at 61 centres across 12 countries, including the US, UK, France, and Germany, between July, 2020, and August, 2022....The results 'suggest that fremanezumab was effective in a difficult-to-treat clinical population with migraine and comorbid major depressive disorders and may also be effective in alleviating psychiatric comorbidities, therefore reducing the cumulative burden on patients.'"

Clinical data • Migraine • Pain

Increased infection risk in patients on preventive CGRP-targeting therapies- a meta-analysis and clinical effect assessment. (PubMed, J Headache Pain) - "CGRP has multiple and often potentially opposing effects on the immune system. In effect, preventive CGRP pathway antagonists (especially eptinezumab and galcanezumab) possibly only mildly increase the risk of infections. However, it is unlikely to affect most migraine patients considering relatively high NNH, low effect size and few infectious SAEs reported so far. The result of CGRP-targeting therapies potentially depends on the type of pathogen and patient's immune status. Consequently, in immunocompromised patients or at public health levels the increased infection risk may have more pronounced effect."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Infectious Disease • Migraine • Pain

Identifying signals of disproportionate reporting for calcitonin gene-related peptide inhibitors: real-world evidence from the FDA adverse event reporting system. (PubMed, Expert Opin Drug Saf) - "Galcanezumab showed strong signals for underdose (ROR 47.4; 95% CI 43.79-51.3), alopecia (5.72; 5.09-6.43), and constipation (6.01; 5.35-6.75), while fremanezumab exhibited notable associations with alopecia (6.9; 5.72-8.33) and weight increased (6.34; 5.18-7.76). Among gepants, rimegepant was linked to somnolence (4.52; 3.57-5.73) and dizziness (3.73; 3.15-4.42) and atogepant showed a strong signal for therapy interruption (16.58; 12.86-21.38). This study highlights CGRP inhibitor-associated AEs, underscoring the need for clinical monitoring and risk identification. Early detection of AEs and SDRs can inform protective measures to enhance patient safety."

Adverse events • HEOR • Journal • Real-world evidence • Alopecia • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Migraine • Pain

Efficacy of anti-calcitonin gene-related peptide monoclonal antibodies in hemiplegic migraine: a case report and review of literature. (PubMed, Front Neurol) - "We present a case of a middle-aged woman with chronic migraine and recurrent hemiplegic episodes treated with fremanezumab...This case adds to the emerging evidence supporting CGRP mABs as a potential therapeutic option for HM. Further research is needed to elucidate their precise mechanism and determine their efficacy in broader HM populations."

Clinical • Journal • CNS Disorders • Migraine • Pain

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

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