Aimovig (erenumab-aooe) / Amgen, Novartis - LARVOL DELTA

Interventions for Migraine and Sleep: A Systematic Review Exploring Their Bidirectional Association. (PubMed, Eur J Neurol) - "Integrated approaches combining migraine and sleep interventions show promise for symptom management. Further research is needed to refine treatment strategies and assess long-term effects."

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

20150125: Efficacy and Safety of Erenumab in Pediatric Subjects with Episodic Migraine (clinicaltrialsregister.eu) - P2/3 | N=233 | Active, not recruiting | Sponsor: Amgen Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Migraine • Pain • Pediatrics

Meds from Amgen…now offered through TrumpRx DTC platform (Fierce Pharma) - "Amgen’s Humira biosimilar Amjevita, migraine med Aimovig and cholesterol drug Repatha became available through TrumpRx on Monday....Amjevita can be purchased by cash-paying patients for $299 per month, an 80% discount to the med’s list price of $1,484. Aimovig and Repatha are discounted by 62% off their respective list prices, according to the website."

Commercial • Ankylosing Spondylitis • Crohn's disease • Dyslipidemia • Familial Hypercholesterolemia • Idiopathic Arthritis • Migraine • Pain • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

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

Late-Onset Ocular Myasthenia Gravis-Like Symptoms During Erenumab Therapy for Chronic Migraine: A Case Report. (PubMed, Biologics) - "This case illustrates a rare, late-onset, reversible MG-like complication of erenumab. Clinicians should remain alert to ocular manifestations even as delayed adverse effects of anti-CGRP therapy."

Journal • CNS Disorders • Migraine • Myasthenia Gravis • Pain

Network Meta-analysis of Eptinezumab and Erenumab in Chronic Migraine with Medication overuse Headaches (MOH) (AAN 2026) - "Eptinezumab (100 mg and 300 mg) and erenumab 140 mg significantly reduce monthly migraine days and aid remission from medication overuse headache, while erenumab 70 mg shows no significant benefit. All treatments were well tolerated, with no increase in serious adverse events."

Retrospective data • CNS Disorders • Migraine • Pain

Aimovig: Expiry of patents related to CGRP receptor antibodies in EU on Dec 18, 2029 and in US on May 17, 2032 (Amgen) - Annual Report 2025: Expiry of patents related to methods of treatment in EU on Aug 10, 2035 and US on Apr 22, 2036; SPC in France, Italy and Spain and UK until 2033, Expiry of patents related to compositions and pharmaceutical formulations in US on Apr 1, 2039

Patent • CNS Disorders • Migraine • Pain

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

Comparative Efficacy, Safety, and Tolerability of Atogepant and Erenumab: Indirect Treatment Comparison of the TEMPLE and HER-MES Head-to-head Trials (AAN 2026) - "TEMPLE (phase 3b) and HER-MES (phase 4) were head-to-head trials comparing atogepant 60mg once daily or erenumab 70mg or 140mg once monthly to topiramate, respectively. Tolerability and safety were comparable between groups. Atogepant demonstrated significantly higher odds of achieving a ≥50% reduction in MMDs in the overall population at Month 1 and greater MMD reduction in the 8-14 baseline MMD subgroup at Month 1, indicating early onset of atogepant versus erenumab. Efficacy results were comparable at all other time points."

Clinical • Head-to-Head • CNS Disorders • Migraine

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

PRAC adopted a positive recommendation for the ongoing variation assessing the final study report. The study will be removed from the RMP’s pharmacovigilance plan, as evaluation of cardiovascular outcomes in high-risk patients or use in pregnancy is not feasible in a non-interventional PASS, while routine pharmacovigilance including signal detection and PSURs will continue. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 24 – 27 Nov 2025: [AI generated summary]

PRAC • Migraine

Effect of Erenumab on Patient-Reported Outcomes in Episodic Migraine in Asia, the Middle East, and Latin America: Results From the EMPOwER Study. (PubMed, Neurol Clin Pract) - P3 | "These results enhance the evidence for erenumab as an effective preventive therapy for patients with EM. Clinicaltrials.gov/study/NCT03333109."

Journal • CNS Disorders • Migraine • Pain

Aimovig: Regulatory submission for pediatric migraine in 2028 (Novartis) - Q4 2025 Results

Filing • CNS Disorders • Migraine • Pain

Multiple Sclerosis With Migraine and Pyoderma Gangrenosum Treated With Ofatumumab and Erenumab. (PubMed, Cureus) - "She experienced persistent migraines despite valproic acid and sumatriptan use. After the administration of intravenous methylprednisolone (IVMP), ofatumumab treatment was introduced; erenumab was later initiated to manage migraines...The combination therapy demonstrated effectiveness without exacerbating the patient's underlying dermatological condition. This case suggests that combining ofatumumab and erenumab is a viable therapeutic option for patients with MS and comorbid migraine and pyoderma gangrenosum, offering effective disease control with an acceptable safety profile."

Journal • CNS Disorders • Migraine • Multiple Sclerosis • Pain • Pyoderma Gangrenosum