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Aimovig FDA Approval History

Last updated by Judith Stewart, BPharm on May 18, 2018.

FDA Approved: Yes (First approved May 17, 2018)
Brand name: Aimovig
Generic name: erenumab-aooe
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Migraine Prevention

Aimovig (erenumab-aooe) is a calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of migraine.

Dosage and Administration

  • Aimovig is a subcutaneous injection supplied as a 70 mg/mL solution in a single-dose prefilled SureClick® autoinjector or single-dose prefilled syringe.
  • The recommended dosage is 70 mg once monthly, although some patients may benefit from a dosage of 140 mg once monthly (administered as two consecutive injections of 70 mg each).
  • The needle shield within the white cap of the prefilled autoinjector and the gray needle cap of the prefilled syringe contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
  • The injection should be administered subcutaneously into the abdomen, thigh, or upper arm.

Adverse Reactions

The most common adverse reactions in Aimovig clinical studies (occurring in at least 3% of treated patients and more often than placebo) are injection site reactions and constipation.

Development timeline for Aimovig

May 17, 2018Approval FDA Approves Aimovig (erenumab-aooe) as a Preventive Treatment for Migraine
Apr 17, 2018Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig (erenumab) For Migraine Patients With Multiple Treatment Failures
Jan 22, 2018Novartis Reports Erenumab Met All Primary and Secondary Endpoints in Unique Phase IIIb Study in Episodic Migraine Patients Who Have Failed Multiple Prior Preventive Treatments
Nov 29, 2017Aimovig (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention
Nov 29, 2017Novartis Announces Phase III STRIVE Data Published in NEJM Demonstrating Significant and Sustained Efficacy of Erenumab (AMG334) in Migraine Prevention
Sep  7, 2017New Data Demonstrate Aimovig (erenumab) Reduced Monthly Migraine Days In Patients Who Failed Previous Preventive Therapies
Jul 20, 2017FDA Accepts Biologics License Application for Aimovig (erenumab)
May 18, 2017Amgen Submits Biologics License Application to the FDA for Erenumab

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.