FDA Approves Erenumab –  First Among a New Class of Drugs to Prevent Migraines

SUMMARY:  

On May 17, 2018, the FDA approved erenumab, the first drug to prevent migraines by targeting and blocking the activity of calcitonin gene-related peptide (CGRP-R), an important molecule involved in migraine attacks.  Studies demonstrated that using monthly self-administered injections, migraine sufferers experienced a reduction in monthly migraine days (see data below under ‘Supporting Studies’)

Indications 

  • For the preventive treatment of migraine in adults 

Dosage 

  • 70mg once monthly subcutaneously  
    • Some patients may benefit from a dosage of 140mg once monthly administered once monthly as two consecutive injections of 70mg each  
    • Administer in the abdomen, thigh, or upper arm subcutaneously 

KEY POINTS:  

Supporting Studies 

FDA approval based on 3 studies  

  • Study 1
    • 955 participants with a history of episodic migraine  
    • Methods: Compared Erenumab to placebo over 6 months 
    • Findings: Erenumab-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo 
  • Study 2
    • 577 patients with a history of episodic migraine  
    • Methods: Compared Erenumab to placebo over 3 months 
    • Results: Erenumab-treated patients experienced, on average, one fewer migraine day per month than those on placebo 
  • Study 3
    • 667 patients with a history of chronic migraine  
    • Methods: Compared Erenumab to placebo over 3 months  
    • Results: Patients treated with Erenumab experienced, on average, 2 ½ fewer monthly migraine days than those receiving placebo 

Most Common Side Effects 

  • ≥3% of patients experienced injection site reactions and constipation 

Learn More – Primary Sources:

FDA approves novel preventive treatment for migraine 

Prescribing Information for Aimovig