Vyepti (eptinezumab-jjmr) / Teva, Lundbeck - LARVOL DELTA

Levels of migraine controls following International Headache Society (IHS) recommendations with eptinezumab: Effectiveness and tolerability in a 24-week, prospective multicenter study (the TACHIS study). (PubMed, Cephalalgia) - P | "Adverse events were infrequent (4.7%) and mild, with no discontinuations due to safety concerns.ConclusionsEptinezumab demonstrated effectiveness and tolerability in a real-world population of patients with migraine and prior preventive treatment failures. The integration of migraine control metrics provides a comprehensive evaluation of therapeutic impact and supports eptinezumab use in routine care.Trial RegistrationThe TACHIS study was preregistered on clinicaltrial.gov, NCT06409845."

Clinical • Journal • Observational data • 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

Sustained Efficacy of Eptinezumab in Participants with Migraine for Whom Prior Preventive Treatments Failed and Who Self-reported Psychiatric Comorbidities: Post Hoc Analysis of the Placebo-controlled DELIVER Trial. (PubMed, Neurol Ther) - P3 | "Psychiatric comorbidities, including depressive conditions, did not appear to impact the short- or long-term efficacy of eptinezumab in participants with migraine for whom 2-4 prior preventive treatments had failed."

Journal • Retrospective data • CNS Disorders • Depression • Migraine • Pain • Psychiatry

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

Lundbeck reports Q4 results with mixed performance, issues 2026 outlook (Investing.com) - "The company’s key products Vyepti, Abilify franchise, and Trintellix performed ahead of expectations, while Rexulti missed consensus estimates by 9%. Lower gross margins were more than offset by reduced SG&A spending, contributing to the EBITDA beat...While the company appears on track to meet its mid-term targets through 2027, it faces revenue challenges beyond that period as key products Abilify Maintena and Trintellix/Brintellix face generic pressure starting in 2026."

Commercial • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • Depression • Migraine • Pain • Schizophrenia

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

Lundbeck presents new real-world data highlighting meaningful improvements in patients severely impacted by migraine initiating Vyepti (eptinezumab), at HCOP Annual Conference (PRNewswire) - "This analysis reports the findings in participants who successfully completed a full six months of treatment with eptinezumab (n=111)...After two infusions of eptinezumab, 75.7% of participants reported an improvement (any level) in migraine status (95% CI: 66.9%, 82.7%), as measured by the Patient Global Impression of Change Scale (PGIC) with 44.1% reporting "much improved," or "very much improved" (95% CI: 35.3%-53.4%). 44.1% of participants (95% CI: 35.3%-53.4%) reported a ≥50% reduction in monthly headache days (MHDs), with a mean reduction of 6.8 MHDs (95% CI: 5.2-8.3) from a baseline of 20.0 MHDs."

Real-world evidence • Migraine

Eptinezumab to prevent difficult-to-treat migraine: prospective, six-month, real-world multicenter evidence from the GRASP study group. (PubMed, J Headache Pain) - No abstract available

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

BEFREE: The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study) (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: University of Florence | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2025 ➔ Oct 2026

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

CHAIRS: China HeadAche DIsorders RegiStry (clinicaltrials.gov) - P=N/A | N=10000 | Recruiting | Sponsor: Beijing Tiantan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

Migraine worsening after excellent initial response to galcanezumab (EHF-EHC 2025) - "Several prophylactics were tried (topiramate, amitriptyline, and atogepant) with no improvement...However, in the last few months of treatment, she experienced recrudescence of symptoms – she's now awaiting treatment with eptinezumab...While he tried several preventive medications (topiramate, amitriptyline, venlafaxine and valproic acid), he was also medicated with corticosteroids... Recent literature and medical experience refer to Galcanezumab as a good sustained treatment to refractory migraine. However, these cases highlight the situations in which, despite the initial response being great, there's no prolonged effect on pain relief."

Cardiovascular • CNS Disorders • Complement-mediated Rare Disorders • Hepatology • Hereditary Angioedema • Migraine • Pain

Combining anti-CGRP antibodies with atogepant: Safety and efficacy in a patient cohort (EHF-EHC 2025) - "Treatments included erenumab (n=1), fremanezumab (n=11), galcanezumab (n=6), and eptinezumab (n=9). In this real-world cohort, combining antiCGRP mAbs with atogepant appears to be safe and may offer additional benefit."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Insomnia • Migraine • Sleep Disorder

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. More than half of our patients reported significant improvement with antiCGRP therapy. Selfreported adverse events were more frequent (56%) than previously reported. Most frequent, were gastrointestinal symptoms and local skin reactions."

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

Middle meningeal artery lidocaine infusion for refractory migraine: First case report in Portugal (EHF-EHC 2025) - "Various pharmacologic classes were tried without benefit: antihypertensives and calcium channel blockers (propranolol, candesartan, flunarizine), antiepileptics (valproic acid, topiramate, oxcarbazepine), antidepressants (amitriptyline, nortriptyline, venlafaxine, fluvoxamine, sertraline, clomipramine), other preventives (prednisolone, oxitriptan, melatonin), cycles of botulinum toxin (PREEMPT protocol), monoclonal antibodies (galcanezumab, fremanezumab, erenumab), and atogepant. At the time of the procedure, the patient was on eptinezumab 100 mg and botulinum toxin every three months but continued to have daily headaches, with severe intensity and reliance on eletriptan for acute relief... MMA lidocaine infusion has been described in few cases, and this is, to our knowledge, the first reported in Portugal. It constitutes an invasive therapeutic approach that should be considered only as a rescue option for carefully selected patients with severely refractory migraine...."

Case report • Clinical • Anorexia • CNS Disorders • Migraine • Pain

Local cutaneous complications of CGRP monoclonal antibodies: A case series (EHF-EHC 2025) - " Nine women treated with subcutaneous antiCGRP 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... Local cutaneous reactions to subcutaneous anti-CGRP monoclonal antibodies occurred in nearly 5% of patients and were generally mild. 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..."

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

MIGRA-MS: A case series on chronic migraine and multiple sclerosis (EHF-EHC 2025) - "Prior treatments included interferons and glatiramer acetate; current therapies consisted of ocrelizumab, natalizumab, alemtuzumab, teriflunomide, or dimethyl fumarate...All received a median of three classic preventives (amitriptyline in all cases) and onabotulinumtoxinA (PREEMPT, 155 IU) with only one responder; two patients received an extended dose (195 IU) without benefit and later CGRP monoclonal antibodies (galcanezumab, erenumab, eptinezumab) with no response, and atogepant with only transient or partial benefit... Migraine is more prevalent in MS patients than in the general population, and their coexistence represents a therapeutic challenge. In this case series of relapsing–remitting MS with chronic resistant migraine, response to onabotulinumtoxinA and antiCGRP therapies was limited, with no drug interactions or adverse effects observed. An individualized approach and further studies are needed to assess emerging treatments in this subgroup."

Clinical • CNS Disorders • Migraine • Multiple Sclerosis • Pain

Decoding the long-term safety of anti-CGRP (receptor) mAbs: a meta-analysis and systematic review. (PubMed, J Headache Pain) - No abstract available

Journal • Retrospective data • Review • CNS Disorders • Migraine • Pain

H. Lundbeck A/S – VYEPTI®: Advancing migraine prevention through early intentional IV therapy (EHF-EHC 2025) - "This session will explore how 100% bioavailability and rapid onset differentiate VYEPTI® from other anti-CGRP therapies. Real-world evidence and clinical trial data will be presented to examine the potential impact of earlier use of VYEPTI® in the treatment pathway on patient outcomes and disease course."

CNS Disorders • Migraine • Pain

Therapeutic challenges in a rare trigeminal autonomic cephalalgia (EHF-EHC 2025) - "A discrete improvement was noted with intravenous eptinezumab 300 mg every 12 weeks, in combination with duloxetine, gabapentin, topiramate and tapentadol. He makes excessive use of fast-acting tramadol and ibuprofen to alleviate acute pain... SUNCT remains a therapeutic challenge due to its rarity, limited evidence base, and frequent refractoriness. This reinforces the need for further research and therapeutic innovation."

Rheumatology

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

Real-world effectiveness of eptinezumab in participants in whom ≥1 prior anti-cgrp preventive treatment had failed: Results for the first 75 participants in an ongoing prospective study (EHF-EHC 2025) - "Participants for whom prior anti-CGRP therapies have failed experienced, on average, improvements across multiple participant-reported migraine outcomes after escalation to eptinezumab treatment."

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

Eptinezumab and onabotulinumtoxinA in the treatment of chronic migraine: A real-world evidence study (EHF-EHC 2025) - "OnabotulinumtoxinA deserves investigation as useful as add-on therapy to monoclonal antibodies directed towards the signaling of the calcitonin-gene related peptide (CGRP) or its receptor antagonists, gepants, for chronic migraine, also in older patients, and MOH. References 1. Corasaniti MT et al."

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

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... Eptinezumab offers distinct advantages. 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

Efficacy of eptinezumab during a migraine attack: Preliminary data from an Italian multicenter realworld experience (the BEFREE study) (EHF-EHC 2025) - "During the first 30 minutes of the infusion, eptinezumab demonstrated to induce a rapid resolution of migraine pain intensity and associated symptoms, suggesting a peripheral site of pharmacological action for CGRP blockade."

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

Eptinezumab 100 mg infusion every one or two months in the prevention of severe chronic migraine : A faisability study in a French headache centre (EHF-EHC 2025) - "Administering 100mg of eptinezumab every 4to8 weeks appears to be a relevant alternative for patients who are partial or non responders to the quartely regimen. Recognition of this practice in France could support its broader implementation, allow for controlled studies"

CNS Disorders • Migraine • Pain