First Antibody Therapy Approved for Migraine Headaches | FDA

The US FDA has approved the first antibody therapy, erenumab (Aimovig®) for the prevention of migraine headaches.

Key Points

  • Human monoclonal antibody
  • Calcitonin-gene related peptide (CGRP) antagonist
  • 1-2.5 fewer migraines/month
  • Once-monthly self-injectable
  • $6900/year before insurance and discounts
  • Adverse effects: Injection site reactions and constipation


  • 3 Phase III studies w/ 2179 Patients


What is a monoclonal antibody drug?

Monoclonal antibody drugs are a novel class of therapeutics that harness antibodies – immune system proteins that normally locate and destroy bacteria, viruses, and toxins – to target malfunctioning molecules in your body.

What is CGRP?

Calcitonin-gene related peptide (CGRP) is a hormone that mediates pain sensation and causes vasodilation.  CGRP appears to play a role in the development of migraine headaches.


Source: Press Announcements > FDA approves novel preventive treatment for migraine