Migraine: anti-CGRP monoclonal antibody may progress to phase 3 trials

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  • Galcanezumab has a favorable safety and tolerability profile in patients with episodic migraine.

Why this matters

  • Many patients are refractory to migraine prophylaxis , so it is important to always be looking for diverse and novel therapies that may work in these patients.
  • 1 article suggested “cautious excitement” may be warranted for development of anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies for the prophylaxis of migraine. 

Study design

  • Randomized controlled study of 410 patients (galcanezumab, n=273; placebo, n=137) with episodic migraine.
  • Funding: None.

Key results

  • Patients in the galcanezumab group reported serious adverse events like appendicitis, Crohn’s disease, suicidal ideation, and congenital ankyloglossia (which occurred in a male infant whose father was treated with galcanezumab).
  • Discontinuation as a result of adverse events was seen in 3 patients in the galcanezumab group because of abdominal pain, visual impairment, and upper limb fracture.
  • Injection-site reactions reported more frequently in the galcanezumab group (P≤.05) and injection-site pain was most common injection-site adverse event (P≤.004).
  • Frequency of upper respiratory tract infection and nasopharyngitis was higher in the galcanezumab group vs placebo group.
  • Hypersensitivity events were seen in 3.3% of patients in the galcanezumab group vs 5.1% in placebo group.


  • Short duration of the study.

Coauthored with Anand Ramanathan, PharmD