Aimovig Approval History
Reviewed on May 18, 2018 by J.Stewart B.Pharm
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.
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 History and FDA Approval Process for Aimovig
|May 17, 2018|| FDA Approves Aimovig (erenumab-aooe) as a Preventive Treatment for Migraine|
|Apr 17, 2018||Amgen 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, 2018||Novartis 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, 2017||Aimovig (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention|
|Nov 29, 2017||Novartis Announces Phase III STRIVE Data Published in NEJM Demonstrating Significant and Sustained Efficacy of Erenumab (AMG334) in Migraine Prevention|
|Sep 7, 2017||New Data Demonstrate Aimovig (erenumab) Reduced Monthly Migraine Days In Patients Who Failed Previous Preventive Therapies|
|Jul 20, 2017||FDA Accepts Biologics License Application for Aimovig (erenumab)|
|May 18, 2017||Amgen Submits Biologics License Application to the FDA for Erenumab|
|Nov 16, 2016||Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In Second Phase 3 Study|
|Sep 28, 2016||Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In First Phase 3 Study|
|Sep 15, 2016||Amgen Presents Positive Data At EHMTIC 2016 Demonstrating Erenumab Significantly Reduces Monthly Migraine Days In Patients With Chronic Migraine|
|Jun 8, 2016||Amgen Announces Erenumab (AMG 334) Significantly Reduces Patients' Monthly Migraine Days In Phase 2 Study For The Prevention Of Chronic Migraine|
|May 15, 2015||Amgen Presents First Phase 2 Data For AMG 334 In The Prevention Of Episodic Migraine|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.