Is Galcanezumab (galcanezumab) approved for migraine treatment in pediatric patients?

Galcanezumab is Not Approved for Migraine Treatment in Pediatric Patients

Galcanezumab is not approved for migraine treatment in pediatric patients. Based on the FDA drug label, galcanezumab (Emgality) is only indicated for the preventive treatment of migraine in adults and for the treatment of episodic cluster headache in adults 1.

Current Pediatric Migraine Treatment Options

The management of migraine in pediatric patients differs from adults, with specific considerations:

First-line Acute Treatments

• Ibuprofen is recommended as the first-line medication for pain in children and adolescents 2
• For adolescents aged 12-17 years, the following options are approved:
  • Multiple NSAIDs
  • Certain triptans (particularly nasal spray formulations of sumatriptan and zolmitriptan) 2

Preventive Treatments

For pediatric patients requiring preventive therapy:

• Propranolol, amitriptyline, and topiramate are commonly used in clinical practice, although their effectiveness in children and adolescents has not been conclusively proven in clinical trials 2
• Evidence for preventive medications in children is limited by high placebo response rates in clinical trials 2

Why Galcanezumab is Not Used in Pediatric Patients

1. No FDA Approval: The FDA label for Emgality (galcanezumab) does not include any indication for pediatric use 1

2. Limited Research: Current clinical guidelines classify CGRP monoclonal antibodies like galcanezumab as third-line medications for adults, after failure of first-line (beta blockers, topiramate, candesartan) and second-line options (flunarizine, amitriptyline, sodium valproate) 2

3. Age-Specific Considerations: Migraine presentations in children differ from adults - attacks are often shorter, headache is more often bilateral, and gastrointestinal disturbances are more prominent 2

Clinical Implications

Healthcare providers treating pediatric migraine patients should:

• Focus on approved treatments for this age group, primarily ibuprofen for acute treatment 2
• Consider age-appropriate dosing and formulations
• Be aware that triptans have demonstrated efficacy in adolescents but less so in younger children 2
• Recognize that preventive therapy options remain limited to traditional medications like propranolol, amitriptyline, and topiramate 2

Caution

While galcanezumab has shown efficacy for episodic cluster headache in adults 2, this indication also does not extend to pediatric patients. The drug should not be used off-label in pediatric populations without substantial evidence supporting its safety and efficacy in this age group.