Ajovy (fremanezumab-vfrm) / Otsuka, Teva, Hanmi, NeuroGen Pharma - LARVOL DELTA

Fremanezumab-Associated Ischemic Colitis: A Novel Adverse Effect of Anti-CGRP Monoclonal Antibody Therapy (ACG 2026) - "There is also an unmet clinical need for immediate reversal options of anti-CGRP mAbs. Figure: Figure 1: Erythema and Edema seen on initial presentation Figure: Figure 2: Post-Hemicolectomy"

Adverse events • Cardiovascular • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Migraine

Distribution and target engagement of peripherally administered fremanezumab in the cerebrospinal fluid of healthy volunteers. (PubMed, Headache) - "The present findings suggest the rapid distribution of fremanezumab into the central nervous system after peripheral administration, and the persistent retention of fremanezumab and target engagement of CGRP in the CSF. Further studies are required to determine whether entry into the CSF and target engagement play a role in the clinical efficacy of fremanezumab observed in people with migraine."

Journal • CNS Disorders • Migraine • Pain

Proactively Intervening On Early Cranial Nerve Injury As A Delayed Sequela Of Oropharyngeal Cancer: A Randomized Feasibility Clinical Trial For Pro-Habilitation (proNERVE RCT) (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Otorhinolaryngology • Solid Tumor

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

Depressive and anxiety symptoms during CGRP-targeted migraine prevention: A systematic review and meta-analysis. (PubMed, Cephalalgia) - "In the single placebo-controlled subgroup analysis, fremanezumab was numerically superior to placebo for depressive outcomes, though this difference did not reach statistical significance.ConclusionsCGRP-targeted therapies were consistently associated with reductions in depressive and anxiety symptom scores across multiple validated instruments, with improvements appearing to correlate with effective migraine control, although current study designs cannot differentiate between direct and indirect effects on psychiatric symptoms. Placebo-controlled evidence remains insufficient to draw firm conclusions, and adequately powered randomized controlled trials with psychiatric outcomes as prespecified endpoints are warranted before the nature and magnitude of these effects can be definitively characterized."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Depression • Migraine • Mood Disorders • Pain • Psychiatry

Anti-CGRP Monoclonal Antibodies in Chronic Migraine: A Position Statement of the Brazilian Academy of Headache and Orofacial Pain. (PubMed, Cureus) - "The electronic survey consisted of 49 structured questions that addressed clinical experience with CM, the prevalence of comorbid medication-overuse headache (MOH), the use of anti-CGRP mAbs fremanezumab and galcanezumab as treatment options, comparative assessment, therapeutic positioning, and consensus statements. Conclusions Diagnostic delays, high treatment resistance, and significant comorbidity burden characterize CM management in Brazil. In the opinion of the surveyed specialists, anti-CGRP mAbs are perceived as effective and well tolerated, particularly in patients with MOH, and most respondents favored their earlier positioning in the treatment algorithm."

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, 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

New Migraine Guidelines Expand Treatment Options For Migraine Prevention (RTTNews) - "The guidelines discuss how preventive medicines are different from medicines used to treat a migraine attack after it starts...The new guidelines recommend atogepant, erenumab, fremanezumab, galcanezumab, and eptinezumab as first-choice medicines for preventing migraine. These medicines are given in different ways...For people with episodic migraine, meaning migraine occurring on fewer than 15 days a month, the treatments with the strongest evidence of effectiveness include atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, propranolol, topiramate, and valproate....Botox is also an option for chronic migraine."

Clinical guideline • Migraine

Efficacy and Safety of Fremanezumab in Episodic Migraine: A Systematic Review and Meta-analysis. (PubMed, Ann Pharmacother) - "Fremanezumab is an effective and generally well-tolerated preventive treatment for episodic migraine. Evidence is robust in adults, whereas pediatric findings remain preliminary and warrant confirmation in future randomized trials."

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

Fremanezumab for migraine in children and adolescents: A promising option for Pakistan. (PubMed, J Pak Med Assoc) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Improving the Perception of Stress and Mutuality in Caregivers (MI-DEAR Study) of Migraine Patients With Depressive Symptoms Treated With Fremanezumab: A Study to Evaluate Whether Fremanezumab Reduces the Impact on Caregivers and Increases Couple Reciprocity (clinicaltrials.gov) - P=N/A | N=308 | Completed | Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting ➔ Completed | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion • Trial primary completion date • 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

Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45 (clinicaltrials.gov) - P4 | N=15 | Completed | Sponsor: Brigham and Women's Hospital | Active, not recruiting ➔ Completed | N=72 ➔ 15

Enrollment change • Trial completion • CNS Disorders • Migraine

Epidural Blood Patch: An Unexpected Solution to Obstructive Sleep Apnea Headache (ASA 2026) - "Despite previous Ajovy injections, Botox injections, and a Cymbalta regimen, patient had no improvement in cervical pain and headaches. Patient had C2-4 medial branch nerve block without relief and bilateral occipital nerve block with minor relief. Patient suspected to have dural tears secondary to OSA and had L2/L3 epidural blood patch placed which resulted in immediate relief and return to activities of daily living."

Musculoskeletal Pain • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Fremanezumab for the preventive treatment of migraine in Chinese adults: A Phase 3, randomized controlled trial with an open-label extension. (PubMed, Cephalalgia) - P3 | "Fremanezumab demonstrated a favorable safety profile, with no safety signals. These results are comparable to pivotal adult trials in Europe and the US, supporting the use of fremanezumab in Chinese adults living with migraine.Clinical trial pre-registrationClinicalTrials.gov identifier: NCT05458011; submitted: 11 July 2022; first participant enrolled: 30 September 2022; available at: https://clinicaltrials.gov/study/NCT05458011; first submitted: 11 July 2022)."

Clinical • Journal • P3 data • CNS Disorders • Migraine • Pain

Ultrasound assessment of cerebrovascular risk via breath-holding index in migraine patients treated with anti-CGRP monoclonal antibodies: a pilot study. (PubMed, J Ultrason) - "Additionally, a subanalysis revealed no significant differences based on the specific monoclonal antibody (erenumab, fremanezumab, or galcanezumab) or clinical response status (responders versus non-responders). Our findings suggest that treatment with anti-CGRP monoclonal antibodies is not associated with a BHI indicative of increased cerebrovascular risk. Notably, this is the first study to include galcanezumab and fremanezumab in the evaluation of cerebrovascular risk using ultrasound, highlighting TCCD ultrasonography as a practical and non-invasive tool for the assessment of cerebrovascular reactivity in migraine."

Journal • CNS Disorders • Migraine • Pain

Key Innovative brands continued to drive growth while transforming Teva’s portfolio mix and financial profile (The Manila Times) - "AUSTEDO continued to grow rapidly, with global revenues of $696 million, growing 40% YoY in LC; AJOVY global revenues of $244 million, increasing 56% YoY in LC."

Sales • CNS Disorders • Huntington's Disease • Migraine

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

Tumor Expression of CGRP Confers Sensitivity to Growth Inhibition by the Anti-CGRP Antibody Fremanezumab. (PubMed, Eur J Pharmacol) - "In keeping with the tumorigenic role of CGRP, several studies report anticancer effects of rimegepant, a CGRP receptor antagonist. The antibody, however, by altering ERK signaling, might counteract MAPK-dependent growth signaling in CGRP-expressing tumors. Collectively, our findings disclose for the first time the tumorigenic effects of CGRP released from cancer cells and suggest the translational potential of clinically available anti-CGRP monoclonal antibodies as a therapeutic strategy for cancer."

Journal • CNS Disorders • Migraine • Oncology • Pain • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma

CGRP-pathway exposure during the pre-EBP interval in spontaneous intracranial hypotension: an exploratory retrospective case series. (PubMed, BMC Neurol) - "These observations are hypothesis-generating only and report temporal associations between CGRP-pathway initiation and short-term symptom changes in a highly selected cohort with comorbid chronic migraine. They do not demonstrate efficacy for SIH and should not be interpreted as endorsing CGRP-pathway therapy as a treatment for SIH. Prospective, controlled trials with validated headache and orthostatic endpoints, stratification by migraine status, and peripheral/CSF biomarker assessments are required."

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

Early and clinically meaningful functional improvement following CGRP monoclonal antibodies in adolescents with migraine: A real-world retrospective study. (PubMed, Cephalalgia) - "We aimed to evaluate early functional outcomes in daily and school activities, as well as headache-related outcomes after initiating CGRP mAb therapy in Japanese adolescents with migraine.MethodsThis single-center retrospective cohort study included patients aged 15-17 years who received CGRP mAb therapy (galcanezumab, fremanezumab or erenumab) for migraine between May 2021 and July 2025. Safety and tolerability findings are particularly notable given the limited evidence in this age group. Further prospective controlled studies are warranted to validate these findings and to identify predictors of early functional response."

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

Expanding preventive options for pediatric migraine: the use of anti-CGRP monoclonal antibodies for children and adolescents with migraine. (PubMed, Transl Pediatr) - No abstract available

Journal • CNS Disorders • Migraine • Pain • Pediatrics

Three-Year Interim Results from a Post-Marketing Surveillance Study of Patients with Migraine Treated with Fremanezumab in South Korea. (PubMed, Drugs Real World Outcomes) - "Fremanezumab was well tolerated and effective for migraine prevention in Korean adults in a real-world setting. These results support the use of fremanezumab in routine clinical practice across South Korea."

Journal • P4 data • CNS Disorders • Migraine • Pain