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

Lundbeck announces headline results from Phase IV THRIVE trial evaluating VYEPTI (eptinezumab) following inadequate response to prior CGRP-targeting preventive therapy (PRNewswire) - "Primary endpoint analysis of the clinical Phase IV THRIVE trial showed that 60% of participants reported being 'much improved' or 'very much improved' following treatment with eptinezumab. Results provide prospective clinical data on the use of eptinezumab in adults with migraine following inadequate response to one prior CGRP-targeting preventive therapy. Eptinezumab was generally well tolerated with no new safety signals identified in this population. Full results from the trial will be presented at upcoming scientific congresses."

P4 data • Migraine • Pain

Persistence and Reasons for Treatment Discontinuation of Anti-CGRP Therapies in Migraine Prophylaxis: A Systematic Review and Meta-analysis of Real-World Studies. (PubMed, Pain Ther) - "Approximately three-quarters of patients remain on anti-CGRP therapy at 1 year, with most discontinuation occurring within the first six months and driven mainly by perceived lack of efficacy rather than tolerability. Marked between-study heterogeneity warrants cautious interpretation and more standardized reporting of persistence in future real-world studies."

Journal • Real-world evidence • Retrospective data • Review • CNS Disorders • Migraine • Pain

Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context (clinicaltrials.gov) - P3 | N=102 | Enrolling by invitation | Sponsor: Dr George Medvedev | Trial completion date: Dec 2025 ➔ Mar 2028 | Trial primary completion date: Dec 2025 ➔ Mar 2028 | Not yet recruiting ➔ Enrolling by invitation

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

Anti-calcitonin gene-related peptide treatments in women's health: Gaps and clinical evidence in menstrual-related migraine, pregnancy, lactation, and hormonal contraception: A narrative review. (PubMed, Headache) - "Substantial evidence gaps exist across all reproductive health contexts examined. Prospective trials in menstrual-related migraine, pregnancy registries, lactation studies assessing infant outcomes, and research examining interactions with hormonal contraceptives are needed to optimize migraine care for women."

Journal • Review • CNS Disorders • Migraine • Pain • Women's Health

Real-World Effectiveness and Safety of Anti-CGRP Monoclonal Antibodies in the Prevention of High-Frequency Episodic and Chronic Migraine in Romania-A Multicenter Retrospective Observational Study. (PubMed, Biomedicines) - " We conducted a multicenter retrospective observational cohort study including 113 adults with HFEM (n = 38) or CM (n = 75) who initiated treatment with galcanezumab, erenumab, fremanezumab, or eptinezumab at specialized headache centers in Romania. The treatment was generally well-tolerated, with predominantly non-serious adverse events and a low rate of discontinuation due to adverse events. These findings provide real-world evidence from Romania and support further prospective evaluation of the long-term effectiveness and safety of anti-CGRP monoclonal antibodies."

Journal • Observational data • Real-world evidence • Retrospective data • CNS Disorders • Migraine • Pain

Lundbeck receives marketing authorization for Vyepti (eptinezumab) in Japan for the prevention of migraine attacks (PRNewswire) - "The Japanese marketing authorization is supported by the global clinical development program for eptinezumab, including the Phase III PROMISE-1, PROMISE-2 and DELIVER trials, together with data from the Phase III SUNRISE trial, which evaluated efficacy and safety in a predominantly Asian population with chronic migraine. The application was further supported by the Phase III SUNSET long-term extension study conducted specifically in Japanese patients to evaluate the long-term safety of eptinezumab."

Japan approval • Migraine • Pain

Drugs for prevention of migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Comparison table: Some drugs for migraine prevention. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Goal Attainment and Satisfaction With Eptinezumab Treatment in Participants in Whom =1 Prior CGRP-Targeted Preventive Therapy Had Failed: 12-Month Results From the INFUSE Study (PAINWeek 2026) - "In the full analysis population (N=190), 57.9% (110/190) of participants reported setting goals for their migraine treatment in partnership with a physician. Of the participants who set goals for their treatment (n=110), 47.3% (52/110) set ≥4 goals, 13.6% (15/110) set 3 goals, 11.8% (13/110) set 2 goals, and 27.3% (30/110) set 1 goal. Participants most commonly reported symptom reduction (i.e., reduction in symptom frequency, severity, or duration or improvement in bothersome symptoms; 94.5% [104/110]), followed by improvement in their ability to participate in daily activities (56.4% [62/110]) and improvement in their ability to participate in family or social life (46.4% [51/110]), as their treatment goal."

CNS Disorders • Migraine

Real-World Characteristics and Outcomes in Adults with Chronic Migraine Receiving Eptinezumab at the Cleveland Clinic (PAINWeek 2026) - "At baseline, 40.1% (151/377) of participants had medication overuse headache, 88.6% (334/377) had anti-CGRP mAb experience, and 46.2% (174/377) reported daily headache that limited normal activities. Eptinezumab treatment was associated with a decrease in the median (IQR) monthly number of days headache limited normal daily activities, from 28 (20.0, 30.0) days at baseline to 25.0 (15.0, 30.0) days after the first infusion. Reductions in days affected by headache were sustained after the second infusion of eptinezumab."

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

Systematic Review of Pharmacologic Treatment for Migraine Prevention in Adults: Report of the AAN Guidelines Subcommittee and the American Headache Society. (PubMed, Headache) - "This SR provides a comprehensive synthesis of evidence on pharmacologic migraine prevention in adults. High- and moderate-confidence findings confirm the efficacy of several established and newer preventive therapies and demonstrate improvements in patient-reported outcomes across multiple validated measures. These conclusions informed the development of evidence-based recommendations, presented in a companion publication, to guide clinicians in selecting preventive medications for adults with episodic and chronic migraine."

Journal • CNS Disorders • Migraine • Pain

Systematic Review of Pharmacologic Treatment for Migraine Prevention in Adults: Report of the AAN Guidelines Subcommittee and the American Headache Society. (PubMed, Neurology) - "This SR provides a comprehensive synthesis of evidence on pharmacologic migraine prevention in adults. High- and moderate-confidence findings confirm the efficacy of several established and newer preventive therapies and demonstrate improvements in patient-reported outcomes across multiple validated measures. These conclusions informed the development of evidence-based recommendations, presented in a companion publication, to guide clinicians in selecting preventive medications for adults with episodic and chronic migraine."

Journal • Review • CNS Disorders • Migraine • Pain

A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications (clinicaltrials.gov) - P4 | N=164 | Completed | Sponsor: H. Lundbeck A/S | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine

Tracking migraine outcomes over time by age and monoclonal antibody type: a retrospective, single-center, real-world study. (PubMed, Front Neurol) - "We conducted a retrospective, single-center observational study including 453 adults with episodic or chronic migraine treated with erenumab, galcanezumab, fremanezumab, or eptinezumab between November 2018 and April 2026. In real-world clinical practice, CGRP mAbs demonstrate comparable and durable effectiveness across age groups. Subtle long-term differences between agents may emerge, particularly for multidimensional clinical improvement, supporting individualized treatment selection."

Journal • Observational data • Real-world evidence • Retrospective data • CNS Disorders • Migraine • Pain

Strong growth from Vyepti nd focused commercial execution drive total revenue growth of +16% CER (+13% CER underlying) in H1 2026 (TradingView) - "Revenue from Lundbeck's strategic brands increased by +17% CER (+11% DKK), reaching DKK 10,463 million, representing 77% of total revenue: Rexulti: DKK 3,297 million (+17% CER; +8% DKK; underlying +16% CER); Vyepti: DKK 2,865 million (+46% CER; +36% DKK; underlying +46% CER); Brintellix/Trintellix: DKK 2,331 million (+0% CER; -2% DKK; underlying -5% CER); Abilify LAI franchise: DKK 1,970 million (+7% CER; +4% DKK; underlying +4% CER)."

Sales • Autism Spectrum Disorder • Bipolar Disorder • Major Depressive Disorder • Migraine • Schizophrenia • Tourette Syndrome

Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT) (clinicaltrials.gov) - P3 | N=80 | Not yet recruiting | Sponsor: Sunnybrook Health Sciences Centre | Trial completion date: Sep 2027 ➔ Dec 2027 | Initiation date: Jan 2026 ➔ Sep 2026

Trial completion date • Trial initiation date

Twelve-months prospective real-world assessment of effectiveness and safety of eptinezumab in migraine patients difficult-to-treat and naïve to CGRP monoclonal antibodies: results of the French FHU INOVPAIN registry. (PubMed, J Headache Pain) - "This French real-word study confirms the effectiveness and safety of eptinezumab in difficult-to-treat patients with migraine who and have failed non-specific preventive migraine treatments and are naïve to Calcitonin Gene Related Peptide monoclonal antibodies."

Clinical • Journal • Real-world evidence • CNS Disorders • Depression • Immunology • Migraine • Mood Disorders • Pain • Psychiatry

Cerebrovascular risk with calcitonin gene-related peptide monoclonal antibodies versus onabotulinumtoxinA in patients with migraine: A real-world pharmacoepidemiologic study in the National Institutes of Health All of Us Research Program. (PubMed, Cephalalgia) - "Adults with migraine initiating CGRP mAbs (erenumab, fremanezumab, galcanezumab, eptinezumab) were compared with initiators of onabotulinumtoxinA from January 2018 through September 2023. Several secondary, subgroup, and supportive analyses remained inconclusive for non-inferiority. Larger adequately powered comparative safety studies are needed."

Clinical • Journal • Real-world evidence • Retrospective data • Cardiovascular • CNS Disorders • Ischemic stroke • Migraine • Musculoskeletal Diseases • Orthopedics • Pain

Chronic migraine management with onabotulinumtoxinA and anti-CGRP/R monoclonal antibodies in an Italian real-world setting: update on therapeutic appropriateness and an emerging role of pharmacy. (PubMed, Front Pharmacol) - "Therapeutic appropriateness is far from reaching the gold standard and an increasing role of pharmacists could improve clinical outcomes."

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

Long-term treatment with Eptinezumab in special treatment situations: Real world data. (PubMed, J Neurol Sci) - "Eptinezumab real-world data demonstrate significant effects on monthly headache days, analgesic days and headache intensity in patients with migraine with multiple prophylactic therapy failures and concomitant depression or other pain disorders."

Journal • Real-world evidence • CNS Disorders • Depression • Mental Retardation • Migraine • Musculoskeletal Pain • Pain • Psychiatry

Cross-response to Calcitonin Gene-Related Peptide monoclonal antibodies in a real-world setting: analysis of prospective data collected in the French FHU InovPain registry. (PubMed, J Headache Pain) - "This real-world study confirms the clinical benefit of switching to eptinezumab in nearly one-third of patients who did not respond to previous subcutaneous CGRP mAbs. It also demonstrates a class effect that is not absolute, as nearly one-quarter of patients showed no cross-response between CGRP mAbs."

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

Stroke risk associated with CGRP pathway inhibitors in adults with migraine: Systematic review and meta-analysis of randomized trials (AHS 2026) - "Trials evaluated eptinezumab, erenumab, fremanezumab, and galcanezumab, with follow-up ranging from 12 to 56 weeks. Available randomized evidence does not suggest an increased risk of stroke or TIA with CGRP pathway inhibitors in adults with migraine. Although longer follow-up and real-world data are needed—particularly in patients with elevated baseline vascular risk—these findings provide reassuring cerebrovascular safety data supporting continued clinical use."

Retrospective data • Review • CNS Disorders • Migraine • Pain

Online interest in calcitonin gene-related peptide-therapies: An infodemiology study using Google trends. (PubMed, Headache) - "Commercial launch was the most consistent driver of public search interest in CGRP-targeting therapies. Media exposure produced additional increases in selected cases, whereas regulatory approvals and clinical trial publications had limited measurable impact. These findings underscore the dominant role of commercial and consumer-facing communication in shaping public awareness of new migraine treatments."

Journal • CNS Disorders • Migraine • Pain

Digital milestones and public interest in CGRP-targeting migraine therapies: An infodemiology study in the United States (AHS 2026) - "Seven FDA-approved preventive therapies were analyzed: erenumab, fremanezumab, galcanezumab, eptinezumab, rimegepant, atogepant, and ubrogepant. In the United States, commercial launches and targeted media exposure are the dominant drivers of public interest in CGRP-targeting therapies, while regulatory approvals and trial publications have limited impact. These findings highlight outsized influence of market entry and consumer-facing media on awareness of CGRP-targeting therapies, underscoring opportunities to strengthen communication around scientific and regulatory milestones. Public search interest in CGRP-therapies in the United States (2017–2025)."

CNS Disorders • Migraine • Pain

Longitudinal Effects of CGRP Monoclonal Antibodies for Migraine Prophylaxis: Impact of Treatment Type and Age Group (EAN 2026) - " We conducted a retrospective, single-centre observational study including 443 adults with high-frequency episodic or chronic migraine treated with erenumab, galcanezumab, fremanezumab, or eptinezumab between 2018 and 2025. In real-world clinical practice, CGRP mAbs demonstrate broadly comparable and durable effectiveness across age groups. Subtle long-term differences between agents may emerge, particularly for multidimensional clinical improvement, supporting individualized treatment selection."

CNS Disorders • Migraine