Galcanezumab: First Global Approval

  title={Galcanezumab: First Global Approval},
  author={Yvette N. Lamb},
Galcanezumab-gnlm (Emgality™; Eli Lilly and Company), hereafter galcanezumab, is a humanized monoclonal antibody against the calcitonin gene-related peptide (CGRP) ligand. A potent vasodilator, CGRP is implicated in nociceptive transmission and migraine pathogenesis. In September 2018, the US FDA approved galcanezumab as a once-monthly subcutaneous injection for the preventive treatment of migraine in adults. In the same month, the EMA issued a positive opinion for galcanezumab for the… 

Eptinezumab for the preventive treatment of migraine.

The pharmacology of eptinezumab and the four studies that led to the approval, two Phase II and two Phase III clinical trials, are reviewed and demonstrated efficacy, tolerability and safety in patients with episodic and chronic migraine are reviewed.

Safety and efficacy of galcanezumab in Taiwanese patients: a post-hoc analysis of phase 3 studies in episodic and chronic migraine

Galcanezumab is a promising therapeutic for the preventive treatment of migraine in the Taiwanese population, as compared to the “All Patients” population included in the study.

Relationship of the Calcitonin Gene‐Related Peptide Monoclonal Antibody Galcanezumab Pharmacokinetics and Capsaicin‐Induced Dermal Blood Flow in Healthy Subjects

Galcanezumab showed dose‐ and concentration‐dependent potent and durable inhibition of capsaicin‐induced dermal blood flow and supported dose selection for the phase 2 proof‐of‐concept study.

A Review of Eptinezumab Use in Migraine

Eptinezumab is a relatively safe drug for the prevention of migraines with treatment-related adverse events occurring at a low frequency and they bear a safe profile in patients with comorbidities like obesity and type 1 diabetes.

The impact of CGRPergic monoclonal antibodies on prophylactic antimigraine therapy and potential adverse events

This review considers the current knowledge on the mechanisms of action, specificity, safety, and efficacy of the above mAbs as prophylactic antimigraine agents, and examines the possible adverse events that these agents may trigger.

Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

Galcanezumab is clinically safe and efficient for the management of migraine, and the use of a higher dose increases its efficacy, according to a systematic review and meta-analysis of all randomized placebo-controlled trials evaluated.

Monoclonal Antibodies Targeting CGRP: From Clinical Studies to Real-World Evidence—What Do We Know So Far?

The latest clinical evidence for the use of anti-CGRP in migraine prevention with emphasis on efficacy and safety outcomes from Phase III and real-world studies is provided.

Current status of calcitonin gene-related peptide-based therapies in migraine: a scoping review

Evidence from animal studies elucidated the role of calcitonin gene-related peptide (CGRP) in the pathophysiology of migraine and two classes of drugs were found efficacious and safe in various clinical trials for the treatment and prevention of migraine.

Calcitonin Gene‐Related Peptide Modulators – The History and Renaissance of a New Migraine Drug Class

Data indicated that the therapeutic site of action of the CGRP‐RAs was peripheral not central; that IV C GRP had most likely evoked migraine through an action at sites outside the blood‐brain barrier; and that migraine pain was therefore, at least in part, peripheral in origin.

Calcitonin Gene-Related Peptide Receptor

This activity will highlight the mechanism of action, monitoring, adverse events, relevant interactions, and other key elements in the clinical setting as relates to the essential points needed by members of an interprofessional team managing the care of patients with migraine.



Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial

Galcanezumab 120-mg and 240-mg monthly injections provided clinical benefits and improved functioning, and the incidence rate of adverse events was low, demonstrating the favorable tolerability profile of galcaneZumab.

Targeting CGRP: A New Era for Migraine Treatment

The evolution from older traditional treatments to the innovative CGRP target drugs that are revolutionizing the way to approach this debilitating neurological disease are highlighted.

Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study

The results from this 3-month Phase 2b galcanezumab study support the initiation of larger Phase 3 trials of longer duration and provide new insights into the pharmacokinetics and mechanism of action of the drug.

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the CGRP Binding Monoclonal Antibody LY2951742 (Galcanezumab) in Healthy Volunteers

Galcanezumab induced a robust, dose-dependent, and durable inhibition of capsaicin-induced increase in dermal blood flow in DBF, supporting the continued clinical development of galcaneZumab for prophylaxis in migraine patients.

Translational Pharmacodynamics of Calcitonin Gene-Related Peptide Monoclonal Antibody LY2951742 in a Capsaicin-Induced Dermal Blood Flow Model

C capsaicin-induced dermal blood flow was used as a target engagement biomarker to assess CGRP activity in nonhuman primates and healthy volunteers and provided the dose-response relationship that assisted in dose selection for the phase II clinical development of LY2951742.

EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use: US prescribing information. 2018

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  • 2018

A phase 3 placebocontrolled study of galcanezumab in patients with chronic migraine: results from the 3-month double-blind treatment phase of the REGAIN study

  • [abstract no. PS89LB]. Headache
  • 2017

IHC 2017: Lilly’s galcanezumab demonstrates positive long-term safety results for up to 12 months in patients with migraine [media release

  • Sep 2017. http://www. lilly .com/
  • 2017