Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, AffaMed Therap, Organon - LARVOL DELTA

MIGRAINE MANAGEMENT GONE AWRY: PULMONARY THROMBOEMBOLISM IN A PATIENT ON GALCANEZUMAB FOR MIGRAINE PREVENTION (CHEST 2025) - No abstract available

Clinical • Cardiovascular • CNS Disorders • Migraine • Pain • Pulmonary Embolism

GALCANEZUMAB-INDUCED RECURRENT SEVERE ANAPHYLAXIS: A CASE REPORT OF PROLONGED HYPERSENSITIVITY (CHEST 2025) - No abstract available

Case report • Clinical • Immunology

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

Headphone headache (AHS 2025) - "She noted that her migraines worsened with the development of scalp allodynia where she became refractory to several pharmaceutical treatments including propranolol, cyproheptadine, amitriptyline, nortriptyline, topiramate, zonisamide, venlafaxine, erenumab, galcanezumab, and magnesium infusions. One case is described in which pain associated with external compression headache in the setting of prolonged headphone use was decreased by onabotulinum toxin injections. We hypothesize that, similar in the treatment of migraine, onabotulinum toxin may work to dampen the central sensitization of the sensory neurons associated with allodynia. More research is necessary to confirm our findings."

CNS Disorders • Depression • Migraine • Musculoskeletal Pain • Pain • Psychiatry

Real world evidence for risk-averse behavior in the prescribing of calcitonin gene-related peptide monoclonal antibodies by headache specialists for the prevention of migraine: A retrospective, cohort study (AHS 2025) - "In an open-label extension study of erenumab 2/383 (0.7%) patients reported a cardiovascular event and no patients reported a cerebrovascular event in a 5 year follow up period (Ashina 2019). Other studies evaluating CGRP mAbs, such as galcanezumab and fremanezumab, are reassuring but largely limited to 1–2 year follow up studies (Yang 2025)...Patients were matched for sex, age, high cholesterol (denoted by an ICD-10 code of E78), diabetes mellitus (ICD-10 codes E10 and E11), onabotulinumtoxin A prescriptions, and duration in database... In our cohort of patients, individuals who received CGRP mAbs were overall less likely to be subsequently diagnosed with HTN, CVA, MI, or constipation, with the lowest rates in the CGRP mAb group prescribed by a headache provider and higher in in the group prescribed a CGRP mAb by a non-headache neurologist. These results suggest that headache providers may be more cognizant of the potential risks and complications of these medications...."

HEOR • Real-world • Real-world evidence • Retrospective data • 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

Longitudinal effects of CGRP pathway-targeting migraine therapies on blood pressure and body mass index: A 12-month retrospective analysis (AHS 2025) - " Using data from electronic health records at Jefferson Headache Center, we conducted a retrospective study of adult patients with naïve use of either gepants (atogepant, rimegepant) or CGRP mAbs (erenumab, fremanezumab, galcanezumab) for migraine prevention. These findings suggest that most CGRP pathway-targeting migraine medications have negligible effects on monthly changes in BP over one year. These BP differences were small in magnitude and of unclear clinical significance. Study limitations include the unbalanced distribution of medications and potential changes in antihypertensive medication regimens during the one-year study period that could not be fully captured in our model."

Retrospective data • 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

Effects of injectable calcitonin gene-related peptide-antagonists on migraine-associated cost burden (AHS 2025) - "To date, three subcutaneous injections have been approved: erenumab-aooe, fremanezumab-vfrm, and galcanezumab-gnlm. While limited by a small sample size, the results support continued prescribing of injectable CGRP antagonists to increase cost savings at this VA medical center. These medications were associated with significant reductions in as-needed visits, abortive medication refills, and patient-reported migraine days. These results highlight the clinical, economic, and humanistic benefits of prescribing injectable CGRP antagonists to patients for migraine prevention."

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

Network meta-analysis comparing efficacy and safety outcomes of atogepant, rimegepant, and galcanezumab in patients with episodic migraine after including CHALLENGE-MIG trial (AHS 2025) - " The NMA included 5 randomized, controlled trials for the preventive treatment of EM (ADVANCE [atogepant 60 mg], BHV3000-305 [rimegepant 75 mg], EVOLVE-1, EVOLVE-2 [galcanezumab 120 mg], and CHALLENGE-MIG [rimegepant 75 mg, galcanezumab 120 mg]). Atogepant 60 mg demonstrated significant improvements in 3 of the 4 efficacy outcomes compared to rimegepant 75 mg and significantly increased odds of achieving ≥50% RR in MMD relative to galcanezumab 120 mg. Other efficacy outcomes were not significantly different. Atogepant 60 mg demonstrated comparable all-cause d/c and TEAEs relative to rimegepant and galcanezumab."

Retrospective data • CNS Disorders • Migraine • Pain

Pregnancy outcomes following exposure to galcanezumab: review of cases from the galcanezumab clinical trials (AHS 2025) - "The pattern of pregnancy outcomes observed in the clinical trials was similar between patients treated with galcanezumab or placebo. However, the small number of cases with complete follow-up information and the limited fetal exposure periods make it difficult to draw conclusions regarding treatment recommendations during pregnancy. Women taking galcanezumab who are pregnant or considering becoming pregnant should discuss the potential risks with their healthcare provider."

Clinical • Review • CNS Disorders • Migraine • Pain

Response to memantine in a patient with refractory chronic cluster headache (AHS 2025) - "Memantine has antagonist activity at NMDA receptors, similar pharmacology to that of magnesium and ketamine, which are also used in headache management...Numerous preventive treatments had been tried over the years, including lithium, carbamazepine, valproic acid, propranolol, topiramate, botulinum toxin, and others...When a diagnosis of cardiomyopathy precluded further use of verapamil, he was switched to galcanezumab 300 mg, which had no effect except his attacks now occurred later in the day... Providers who care for patients with cluster headache should keep memantine in mind as an option for preventive therapy, particularly if other treatments have failed, are not tolerated, or are contraindicated. Higher than standard dosing may need to be tried for optimal effect."

Clinical • Alzheimer's Disease • Chronic Cluster Headache • CNS Disorders • Cognitive Disorders • Dementia • Migraine • Pain

Case report: Atypical onset and recovery of Raynaud's phenomenon with galcanezumab with concurrent rizatriptan (AHS 2025) - "Galcanzeumab was discontinued and amitriptyline was started as preventative. Through initiation and discontinuation of galcanzeumab, the patient used rizatriptan as their abortive agent. It has been documented that triptans can also cause RP. The concurrent use of galcanzeumab and rizatriptan may have expedited the presentation of RP but did not affect recovery after discontinuation of only galcanzeumab."

Case report • Clinical • CNS Disorders • Depression • Migraine • Pain • Psychiatry

Retrospective cohort study of anti-CGRP monoclonal antibody unresponsive migraine individuals treated with atogepant: The RESCUE study. (PubMed, Cephalalgia) - "Prior use of anti-CGRP mAbs included erenumab in 11.4% of participants, galcanezumab in 52.3% and fremanezumab in 86.3%. Five (11.4%) participants discontinued treatment due to side effects.ConclusionsAfter three months of treatment, atogepant led to a clinically meaningful improvement in a subset of participants. It may be a valuable preventive option for individuals unresponsive to anti-CGRP mAbs and warrants further investigation in prospective studies."

Journal • Retrospective data • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Management of local and delayed cutaneous hypersensitivity reactions to anti-CGRP antibodies: implications for continuing treatment. (PubMed, Neurol Sci) - "This protocol offers a practical and effective approach to managing local skin reactions, promoting the continued use of anti-CGRP mAbs for migraine. Its simplicity facilitates implementation even in home-based care settings."

Journal • CNS Disorders • Dermatology • Immunology • Migraine • Pain • Pruritus

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

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

Usefulness of the Support Video "Talking Picture Book" for Overcoming Hesitancy to Start Galcanezumab Therapy. (PubMed, Brain Behav) - "This material was particularly useful for patients with a high number of monthly migraine days who had been hesitant to start the therapy. "Talking Picture Book" is a useful material that complements physicians' explanations of the therapy, and it is desirable that such video materials be adapted for use in other countries in the future."

Journal • Video • 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

Efficacy of monoclonal antibodies against CGRP in migraine patients with fibromyalgia comorbidity: a retrospective monocentric observational study. (PubMed, J Headache Pain) - "We found that in migraine suffereres with FM, anti-CGRP monoclonal antibodies had a similar beneficial effect on migraine as in non-fibromyalgia patients, in addition to reducing somatic pain and global disability from the disease. The anti-CGRP agents, represent a good option for the treatment of migraineurs with fibromyalgia, for which no resolutive therapy is yet available."

Journal • Observational data • Retrospective data • CNS Disorders • Fibromyalgia • Migraine • Musculoskeletal Pain • Pain • Rheumatology

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

Identifying signals of disproportionate reporting for calcitonin gene-related peptide inhibitors: real-world evidence from the FDA adverse event reporting system. (PubMed, Expert Opin Drug Saf) - "Galcanezumab showed strong signals for underdose (ROR 47.4; 95% CI 43.79-51.3), alopecia (5.72; 5.09-6.43), and constipation (6.01; 5.35-6.75), while fremanezumab exhibited notable associations with alopecia (6.9; 5.72-8.33) and weight increased (6.34; 5.18-7.76). Among gepants, rimegepant was linked to somnolence (4.52; 3.57-5.73) and dizziness (3.73; 3.15-4.42) and atogepant showed a strong signal for therapy interruption (16.58; 12.86-21.38). This study highlights CGRP inhibitor-associated AEs, underscoring the need for clinical monitoring and risk identification. Early detection of AEs and SDRs can inform protective measures to enhance patient safety."

Adverse events • HEOR • Journal • Real-world evidence • Alopecia • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Migraine • Pain