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

Comparing eptinezumab with onabotulinumtoxinA in the treatment of chronic migraine: a real-world evidence study. (PubMed, J Headache Pain) - No abstract available

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

Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment. (PubMed, Sci Rep) - "Upper respiratory infections were more frequent (RR = 1.49, P = 0.04), while dizziness, nausea, and fatigue showed no significant differences. Eptinezumab shows promise but warrants further research on safety in vulnerable populations and real-world settings."

Adverse events • Clinical • Journal • Review • CNS Disorders • Fatigue • Infectious Disease • Migraine • Pain • Respiratory Diseases

Eptinezumab for migraine prevention after other treatments fail: a plain language summary of publications. (PubMed, Pain Manag) - No abstract available

Journal • CNS Disorders • Migraine • Pain

FACEpi: Facilitators and Barriers to Eptinezumab Administration in Thailand (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Chulalongkorn University

New trial • CNS Disorders • Migraine • Pain

CACS: Clinical advantages of cGRPi switch, a retrospective observational study (AHS 2025) - "The advent of calcitonin gene-related peptide (CGRP) antagonists—such as erenumab (a receptor blocker) and galcanezumab, fremanezumab, eptinezumab (ligand blockers)—offers a novel targeted approach. CGRP antagonists demonstrate efficacy in managing migraines but require better data collection and patient monitoring to optimize outcomes. Continuous monitoring, personalized treatment strategies, and further research are necessary to improve clinical decision-making and healthcare efficiency. FIGURE 1."

Observational data • Retrospective data • CNS Disorders • Migraine • Pain

Retention rates across clinical trials of anti-CGRP monoclonal antibodies for migraine prevention (AHS 2025) - "Similar trials with other anti-CGRP mAbs relative to PREVAIL (ie, long-term [≥48-week] trials in chronic migraine [CM]) were included: REGAIN (galcanezumab), phase 2 trial (erenumab) and HALO CM (fremanezumab). Eptinezumab demonstrated high, long-term retention rates for preventive treatment in participants with CM and in those with migraine for whom 2-4 prior migraine preventive treatments have failed. These findings suggest a high level of participant satisfaction with continued treatment of eptinezumab."

Clinical • CNS Disorders • Migraine • Pain

Dual calcitonin gene-related peptide antagonists for chronic migraine prevention (AHS 2025) - "These medications are divided into monoclonal antibodies, "-mAbs" (erenumab, fremanezumab, galcanezumab, and eptinezumab) and small molecule "-gepants" (rimegepant and atogepant)...Common prior or concurrent non-CGRP antagonist migraine preventive medications included topiramate (84%), tricyclic antidepressants (76%), and onabotulinumtoxinA (73%)... In our small sample, dual preventive CGRP antagonist use was well-tolerated and may be considered for patients with chronic migraine who are resistant to usual treatment. However, larger studies are needed to confirm the safety and efficacy of this approach."

CNS Disorders • Depression • Migraine • Mood Disorders • Pain • Psychiatry

Long-term persistence of patients with chronic migraine switching to onabotulinumtoxinA or a different calcitonin gene-related peptide monoclonal antibody (CGRP mAb) after initial CGRP mAb treatment (AHS 2025) - "This study included patients who had ≥1 claims of a CGRP mAb, then initiated another CGRP mAb (erenumab, fremanezumab, galacanezumab, eptinezumab) or onabotA for 12-24 months post-index. This retrospective, real-world study demonstrated that patients with CM who switched to onabotA treatment after an initial CGRP mAb were more likely to remain persistent on therapy for 12-24 months compared to patients with CM who switched to another CGRP mAb."

Clinical • CNS Disorders • Migraine • Pain

Real-world switch rates of injectable migraine preventive therapies in patients with chronic migraine (AHS 2025) - "The primary endpoint was treatment switching, defined by the occurrence of ≥1 claim for a different branded migraine preventive treatment (onabotA, CGRP mAb, or atogepant) in the 12 months following the index date... A total of 1869 patients met the study inclusion criteria, of which 723 initiated onabotA and 1146 initiated a CGRP mAb (303 erenumab, 308 fremanezumab, 517 galcanezumab, 18 eptinezumab) as their index therapy... Chronic migraine patients on a CGRP mAb were significantly more likely to switch to a different branded migraine preventive treatment within 12 months of treatment initiation compared to those on onabotA."

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

An interdisciplinary approach to medication overuse headache: A case study (AHS 2025) - "She had tried and failed Botulinum toxin injections, occipital nerve blocks and trigger point injections, sphenopalatine ganglion blocks, Amitriptyline, Propranolol, Venlafaxine, Emgality, Aimovig, Vyepti, Qulipta, and Cefaly. The interdisciplinary model with headache neurology, occupational therapy, pain psychology, and physical therapy allowed for continued reinforcement and collaborative integration to allow for a more in-depth assessment of the barriers contributing to medication overuse headache and the implementation of a successful, sustainable plan. The patient was successfully able to stop Excedrin and reduce Sumatriptan use significantly, implement self-regulation and cognitive strategies for pain and anxiety management, and reduce her monthly headache and migraine days by more than 75%. Emotion wheel"

Case study • Clinical • CNS Disorders • Cognitive Disorders • Depression • Migraine • Mood Disorders • Musculoskeletal Pain • Neuralgia • Pain • Psychiatry

Characteristics and eptinezumab infusion experience in participants in whom ≥1 prior preventive anti-CGRP treatment had failed: Interim results of an ongoing real-world study (AHS 2025) - "INFUSE includes adults ≥18 years of age with a diagnosis of migraine in whom ≥1 preventive a-CGRP treatment had failed (erenumab, fremanezumab, galcanezumab, atogepant, or rimegepant [prescribed every other day]). Results of this interim analysis of the INFUSE study indicate that individuals with migraine initiating eptinezumab treatment after ≥1 prior a-CGRP preventive treatment had failed typically have a long history of disease, severe migraine, and have cycled through three or more a-CGRP preventive treatments. The level of concern about initiating an IV treatment was low, and participants generally had a positive infusion experience."

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

Eptinezumab Treatment was Associated with Longer Interictal Periods and Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial (AHS 2025) - P3 | "In this post-hoc analysis, the longest interictal period was larger with eptinezumab compared with placebo during the first 24 weeks of the DELIVER trial. Among participants with >14- and >21-day longest interictal periods, responder rates for patient-reported QoL outcomes were consistently higher with eptinezumab compared with placebo."

HEOR • Retrospective data • CNS Disorders • Migraine • Pain

Sustained reductions in monthly headache days with long-term eptinezumab treatment for chronic migraine: Post-hoc analysis of the phase 3 PREVAIL study (AHS 2025) - "More than half of the participants who achieved ≥50% or ≥75% reduction in MHDs following the first or second dose continued to experience reductions in headache frequency with ongoing eptinezumab treatment. This suggests that an early response may serve as a predictor of sustained response."

P3 data • Retrospective data • CNS Disorders • Migraine • Pain

Impact of participant-reported ≥75% increase in good days/month on migraine symptoms, quality of life, and brain fog: results of the REVIEW real-world study of adults with chronic migraine treated with eptinezumab (AHS 2025) - "An increase of at least 75% in good days/month after starting eptinezumab was linked to improvements in participant-reported migraine symptoms, overall well-being, and brain fog. These findings support the use of good days/month as an indicator of the comprehensiveness and effectiveness of migraine preventive treatment."

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

Efficacy and safety of eptinezumab in chronic migraine: A randomized placebo-controlled trial in a predominantly Asian population (AHS 2025) - P3 | "Eptinezumab 100 mg and 300 mg demonstrated statistically significant greater reductions in monthly migraine days versus placebo in a predominantly Asian population with chronic migraine, with efficacy observed as early as Day 1 and sustained through 12 weeks, with a well-tolerated safety profile consistent with previous trials."

Clinical • CNS Disorders • Migraine • Pain

Long-term improvements following ≥50% migraine response to eptinezumab treatment in participants with migraine: Post hoc analysis of the DELIVER trial (AHS 2025) - "Participants with ≥50% migraine response following the initial eptinezumab dose experienced improvements over Weeks 1–12 in MMDS, headache-related impact, and presenteeism, and reductions in the percentage of remaining migraine attacks that were severe. Benefits of eptinezumab (100 and 300 mg) were sustained for 18 months."

Retrospective data • CNS Disorders • Migraine • Pain

Eptinezumab and patient education in chronic migraine and medication-overuse headache: Results from the randomized, placebo-controlled RESOLUTION trial (AHS 2025) - P4 | "In this study, treatment with eptinezumab led to statistically significant reductions in frequency of migraine days, monthly acute medication use, and pain severity when compared to placebo in participants with CM and MOH who also received a Brief Educational Intervention. These effects were evident across Weeks 1–4, sustained across Weeks 1–12, and extended to all key secondary endpoints."

Clinical • CNS Disorders • Migraine • Pain

New data demonstrates robust efficacy of Vyepti (eptinezumab) in otherwise difficult-to-treat patients with severe migraine (PRNewswire) - P4 | N=609 | RESOLUTION (NCT05452239) | Sponsor: H. Lundbeck A/S | "The study was presented at the 11th Congress of the European Academy of Neurology taking place in Helsinki 21-24 June...In the RESOLUTION trial (n = 608), eptinezumab met the both the primary and secondary endpoints, showing significantly greater monthly migraine day (MMD) reductions through Weeks 1 to 4 with eptinezumab, compared to placebo. Across an average of 21 days, the change from baseline in MMDs was -6.9 with eptinezumab treatment, compared to -3.7 days for placebo (p<0.0001)...Patients also reduced their use of acute medication by more than half with eptinezumab and patient education, where the change from baseline in the number of days per month that patients relied on acute migraine treatment, was -11.2 with eptinezumab, versus -7.8 with placebo (across weeks 1 to 12, p<0.0001, baseline days with acute medication for eptinezumab was 20.1 and for placebo was 20.1)."

P4 data • Migraine • Pain

New data from phase III trial confirms efficacy of Vyepti (eptinezumab) in Asian population with chronic migraine (PRNewswire) - P3 | N=981 | Sunrise (NCT04921384) | Sponsor: H. Lundbeck A/S | "H. Lundbeck A/S (Lundbeck) today announced the full results from the SUNRISE trial...to evaluate the efficacy and safety of eptinezumab versus placebo in a predominantly Asian population with chronic migraine. The study was presented at the 11th Congress of the European Academy of Neurology taking place in Helsinki 21-24 June...In the SUNRISE trial, patients receiving eptinezumab experienced significantly fewer monthly migraine days (MMDs), with eptinezumab offering a -7.5 (300 mg) and -7.2 (100 mg) reduction in MMDs from week 1 through to 12, versus -4.8 with placebo (baseline MMD = 17, p<0.0001 for both 300 mg and 100 mg vs placebo)...In the same study, eptinezumab also demonstrated a rapid onset of preventive efficacy, where more participants reported being free of migraine as early as day 1 after receiving eptinezumab treatment compared to placebo (p<0.002 for 300 mg dose; p<0.01 for 100 mg dose)."

P3 data • Migraine • Pain

P-341: Eptinezumab Treatment was Associated with Longer Interictal Periods and Corresponding Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial (Businesswire) - P3b | N=892 | DELIVER (NCT04418765) | Sponsor: H. Lundbeck A/S | "Lundbeck US...new data at the American Headache Society 67th Annual Scientific Meeting....A post-hoc analysis of the phase 3b DELIVER trial during weeks 1-12 (n=853) and weeks 1-24 (n=832) evaluated the association between the mean longest interictal period and improvements in patient-reported quality of life (QoL) outcomes. Results from this post-hoc analysis indicate the mean longest interictal period was larger with VYEPTI than as reported by patients receiving placebo during the first 24 weeks of the DELIVER trial. Among participants with >14- and >21-day mean longest interictal periods, a greater proportion of participants achieved clinically meaningful improvements in the 6-item Headache Impact test score (HIT-6; ≥5-point total score reduction) and Patient Global Impression of Change (PGIC; 'much improved' or 'very much improved' rating) with VYEPTI compared with placebo."

P3 data • Genetic Disorders • Migraine • Pain • Rare Diseases

P-333: Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention (Businesswire) - "Lundbeck US...new data at the American Headache Society 67th Annual Scientific Meeting....Researchers analyzed select phase 3 clinical trials to assess retention rates for adult participants who were treated with VYEPTI and other anti-CGRP mAbs for the prevention of migraine, including long-term eptinezumab trials: the 104-week, open label, single-arm PREVAIL trial and the 72-week DELIVER trial. In this retrospective cohort study of US claims data, VYEPTI showed high, long-term retention rates for preventive treatment in participants with chronic migraine and in those with migraine for whom 2-4 prior migraine preventive treatments have failed, suggesting a high level of participant satisfaction with continued treatment of VYEPTI. Similar results were observed in other anti-CGRP mAbs in this treatment group."

Retrospective data • Migraine • Pain

P-332: Baseline Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive Anti-CGRP Treatment Had Failed: Interim Results of an Ongoing Real-World Study (Businesswire) - P=NA | N=75 | "Lundbeck US...new data at the American Headache Society 67th Annual Scientific Meeting....INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine initiating VYEPTI for the preventive treatment of migraine. In an interim analysis of the first 75 participants entering the INFUSE study, results indicate that individuals, despite having ≥1 prior a-CGRP preventive treatment, reported a long history of disease and high disease burden (with regard to frequency, severity and cognitive impairments). Interim results also showed that the level of concern about initiating an intravenous (IV) treatment was low and participants in the study generally had a positive infusion experience."

Clinical data • Real-world • Migraine • Pain

Repurposed versus disease-specific medicinals for the prophylaxis of migraine: an updated systematic review. (PubMed, Pain Manag) - "A comprehensive search of PubMed/MEDLINE and ClinicalTrials.gov was conducted to identify phase-3, placebo-controlled trials of gepants (atogepant, rimegepant), anti-CGRP mAbs (eptinezumab, erenumab, fremanezumab, galcanezumab), and traditional treatments (propranolol, topiramate, onabotulinumtoxinA). Anti-CGRP/R medications present a more favorable benefit/risk ratio than traditional treatments. These findings, combined with individual patient histories and preferences, can inform clinical decision-making."

Journal • Review • CNS Disorders • Migraine • Pain

Pharmacokinetics and safety of eptinezumab in children and adolescents with migraine. (PubMed, Headache) - "The PK profile in children and adolescents was consistent across different dose levels and weight groups. These results support the use of weight-based eptinezumab dosing in children and adolescents with migraine. Eptinezumab was generally well tolerated, with no new safety signals observed in this population relative to those observed in adults."

Journal • PK/PD data • CNS Disorders • Hypotension • Migraine • Pain • Pediatrics

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