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

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

Lundbeck raises financial guidance following strong start to the year with strategic brands growth of +24% CER (Lundbeck Press Release) - "The revenue of Lundbeck’s strategic brands increased by +24% CER (+28% DKK), reaching DKK 4,801 million, representing 77% of total revenue: Rexulti: DKK 1,491 million (+28% CER; +34% DKK); Brintellix/Trintellix: DKK 1,254 million (+7% CER; +7% DKK); Vyepti: DKK 1,042 million (+62% CER; +69% DKK); Abilify LAI franchise: DKK 1,014 million (+16% CER; +18% DKK)."

Sales • Major Depressive Disorder • Migraine • Schizophrenia

Cost-Utility Analysis of Migraine Prevention Treatments for Chronic Migraine Headaches Patients in the United States (ISPOR 2025) - "OBJECTIVES: To evaluate the cost-effectiveness of migraine prevention treatments in patients with chronic migraine A hybrid decision-Markov model was constructed to evaluate the cost-effectiveness of prevention medications (eptinezumab, erenumab, and onabotulinumtoxinA) for chronic migraine. Eptinezumab was a cost-effective strategy at a WTP of $50,000 per QALY gained compared to onabotulinumtoxinA. However, onabotulinumtoxinA may be an alternative cost-effective option if eptinezumab was not tolerated by the patient."

Clinical • HEOR • CNS Disorders • Migraine • Pain

Efficacy and Safety of Eptinezumab in Episodic Cluster Headache: A Randomized Clinical Trial. (PubMed, JAMA Neurol) - P3 | "Eptinezumab was generally well tolerated. ClinicalTrials.gov Identifier: NCT04688775."

Clinical • Journal • CNS Disorders • Migraine • Pain

Genetic migraine disorders and the response to calcitonin gene-related peptide antagonist treatment. (PubMed, Headache) - "In this case series, we add to the growing body of evidence that CGRP-blocking medications are safe and effective in some heritable neurological disorders in which vasomodulation is a common underlying pathology. To our knowledge, we present the first cases of galcanezumab use in an individual with mitochondrial encephalopathy with lactic acidosis and stroke-like episodes and eptinezumab in an individual with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy."

Journal • Cardiovascular • CNS Disorders • Metabolic Disorders • Migraine • Pain

A 24-week prospective, multicenter, real-world study on eptinezumab's effectiveness and safety in migraine prevention (EMBRACE II). (PubMed, J Neurol) - "This real-world study documents that 24-week eptinezumab treatment is rapidly effective and well tolerated in migraine patients with multiple therapeutic failures (including anti-CGRP mAbs). One-third of patients escalated to 300 mg at week 12, achieving further significant migraine-related disability reduction."

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

Safety, efficacy, and compliance of moderate-to-high dose eptinezumab and erenumab in chronic migraine patients with medication-overuse headache: an updated systematic review and meta-analysis. (PubMed, J Headache Pain) - "Standard-to-high dose anti-CGRP therapies (eptinezumab, erenumab) effectively reduce monthly migraine days and improve MOH remission rates with minimal adverse effects, showing good tolerability in CM patients with MOH."

Compliance • Journal • Retrospective data • CNS Disorders • Infectious Disease • Migraine • Pain • Respiratory Diseases

EMBRACE: EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine. (clinicaltrials.gov) - P=N/A | N=500 | Recruiting | Sponsor: IRCCS San Raffaele Roma | Trial primary completion date: Dec 2024 ➔ Dec 2025

HEOR • Real-world evidence • Trial primary completion date • CNS Disorders • 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

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache (clinicaltrials.gov) - P4 | N=609 | Completed | Sponsor: H. Lundbeck A/S | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

Long-term safety, tolerability, and efficacy of eptinezumab in chronic cluster headache (CHRONICLE): an open-label safety trial. (PubMed, Lancet Neurol) - P3 | "Eptinezumab was generally well tolerated in participants with chronic cluster headache, with a similar safety profile as previously seen in participants with migraine. Although clinical efficacy over 12 months was observed, randomised controlled trials (when feasible) or trials with an innovative design are needed to confirm the clinical relevance of these observations."

Clinical • Journal • Chronic Cluster Headache • CNS Disorders • Fatigue • Infectious Disease • Migraine • Novel Coronavirus Disease • Pain

PACAP38-induced migraine attacks are independent of CGRP signaling: a randomized controlled trial. (PubMed, J Headache Pain) - P=N/A | "Our results suggest that PACAP38 may mediate its signaling independently of CGRP in migraine pathogenesis. Therapies targeting PACAP signaling are thus a promising new avenue for treating migraine."

Clinical • Journal • CNS Disorders • Migraine • Pain • ADCYAP1

AAN 2025: Lundbeck highlights sustained efficacy of Vyepti for migraine prevention (Yahoo Finance) - P3 | N=128 | PREVAIL (NCT02985398) | Sponsor: Alder Biopharmaceuticals, Inc. | "Post hoc analysis of the long-term, open-label Phase III PREVAIL (NCT02985398) study evaluating two-year safety and patient-reported outcomes with Vyepti in adults with chronic migraine was presented in a poster at AAN 2025. The analysis showed that the majority of the participants who achieved 50% or greater headache response or 75% or greater headache response in the first 12 weeks after receiving their first dose of Vyepti were able to maintain that level of response up to Week 84."

P3 data • Patient reported outcomes • Migraine

AAN 2025: Lundbeck highlights sustained efficacy of Vyepti for migraine prevention (Yahoo Finance) - P3 | N=892 | DELIVER (NCT04418765) | Sponsor: H. Lundbeck A/S | "Sustained treatment response was further demonstrated in another poster presenting post hoc analysis of data from the randomized, placebo-controlled Phase III DELIVER (NCT04418765) trial. In this study, patients had either chronic migraine or high-frequency episodic migraine, and they had failed to respond to two to four prior migraine preventive treatments. Up to 83% of patients who responded to Vyepti treatment within the first one to 24 weeks of the trial (i.e., having received the first two doses of Vyepti) were able to maintain that response over the 72-week trial. These analyses highlight that early treatment response with Vyepti may be able to predict long-term sustained treatment response."

P3 data • Migraine

AAN 2025: Lundbeck highlights sustained efficacy of Vyepti for migraine prevention (Yahoo Finance) - "A third poster focused on patient-reported impact of Vyepti treatment in adults with chronic migraine. It presented a post hoc analysis of the impact of a 75% or greater increase in good days/month in patients treated with Vyepti from a real-world, observational, US-based study. Approximately two-thirds of the patients in the study reported a 75% or greater increase in good days/month, and this was correlated with higher satisfaction regarding the effects of Vyepti on migraine symptom severity, frequency, and duration; daily activities, such as being able to participate in social/family life, being productive, and ability to plan; and overall wellbeing when compared with patient with less than 75% increase in good days/month. Prior to treatment, the prevalence of brain fog was similar across the treatment response subgroup..."

Real-world evidence • Migraine

Pfizer’s Nurtec approved in Korea, intensifying CGRP migraine treatment competition (Korea Biomedical Review) - "The Korean approval of Pfizer’s Nurtec, an oral calcitonin gene-related peptide (CGRP) targeting drug for both acute and preventive treatment, is expected to further intensify competition in the domestic migraine treatment market. According to the Ministry of Food and Drug Safety, Pfizer Korea's oral CGRP receptor antagonist, Nurtec Oral Disintegrating Tablets 75 mg (ingredient: rimegepant sulfate hydrate), was approved as a new drug on March 24....Beyond Nurtec, more migraine treatment options are expected to emerge in Korea. Lundbeck Korea aims to launch its CGRP monoclonal antibody eptinezumab (marketed as Vyepti internationally) in the first half of 2027."

Korea approval • Launch non-US • Migraine

Long-term Maintenance of ≥50% and ≥75% Migraine Response With Eptinezumab in Patients With High-frequency Episodic Migraine and Chronic Migraine and 2-4 Prior Migraine Preventive Treatment Failures (P12-12.005). (PubMed, Neurology) - "Dr. Lipton has received publishing royalties from a publication relating to health care."

Clinical • Journal • CNS Disorders • Migraine • Pain

Successful Management of Wearing-off effect with Eptinezumab: Lessons from a case with Chronic Migraine Refractory to Two Subcutaneous CGRP Antibodies (PubMed, Rev Neurol) - "She failed to respond to multiple oral preventatives, botulinum toxin, and two CGRP antibodies (erenumab and galcanezumab). Conclusions CGRP antibodies can show a wearing-off effect, which should be identified in order to plan individualized treatment and avoid an incorrect interpretation as therapeutic failure. Our case also shows that patients with chronic migraine refractory to two antibodies can respond to a third CGRP antibody, in this case, intravenous eptinezumab."

Journal • CNS Disorders • Migraine • Pain

Efficacy and safety of mAbs anti-CGRP/CGRP R (eptinezumab and erenumab) or atogepant in combination with onabotulinumtoxinA in refractory chronic migraine: a clinical trial protocol. (PubMed, Pain Manag) - "Chronic migraine is a disabling neurovascular disorder that represents the leading cause of years lived with disability in people under 50 with a remarkable social burden due to widespread resistance to the front-line treatments used routinely in current clinical practice. Furthermore, a feasible salivary biomarker of migraine is under investigation in the prospective stage of the study. Based on recent expert opinions supporting the switch to easy-to-use small molecule calcitonin gene-related peptide (CGRP)-targeting, i.e. rimegepant or atogepant in unresponsive patients, the present study may offer to clinicians a novel treatment to enhance the therapeutic preventive machinery in chronic migraine."

Journal • CNS Disorders • Migraine • Pain

Lundbeck to present positive pipeline data at American Academy of Neurology (AAN) Annual Meeting (PRNewswire) - "H. Lundbeck A/S (Lundbeck) will present positive interim results...in addition to new analyses from clinical trials and real-world data with eptinezumab...In addition, Lundbeck will present recent post-hoc analyses and real-world data for eptinezumab investigating meaningful endpoints, such as good days per month, and sustained treatment response."

Clinical data • Migraine

Eptinezumab: Regulatory submission in Asia for migraine prevention in Q4 2025 (Lundbeck) - AGM 2025

Filing • Migraine

Sunrise: Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (clinicaltrials.gov) - P3 | N=981 | Completed | Sponsor: H. Lundbeck A/S | Active, not recruiting ➔ Completed

Trial completion • 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