Aimovig

Treats migraine. BLA 761077, held by Amgen Inc. Erenumab-Aooe.

As of Nov 13, 2026, BLA 761077 (Aimovig), held by Amgen Inc, was first approved by FDA on May 17, 2018, with 13 approved supplements and 0 published complete response letters.

First approved: May 17, 2018
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

AIMOVIG is indicated for the preventive treatment of migraine in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 3, 2022	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 11, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 17, 2018	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aimovig70MG/ML · injectable;injection	Erenumab-Aooe	Rx

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 19, 2025	Supplement 25Labeling · Standard review	Approved	Letter Label
Mar 21, 2025	Supplement 26Labeling · Standard review	Approved	Letter Label
Aug 6, 2024	Supplement 22Labeling · Standard review	Approved	Letter Label
Oct 3, 2022	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 22, 2022	Supplement 17Labeling · Standard review	Approved	Letter Label
Aug 15, 2022	Supplement 16Labeling · Standard review	Approved	Letter
Mar 4, 2022	Supplement 14Manufacturing	Approved	Letter
May 11, 2021	Supplement 11Labeling · Standard review	Approved	Label Letter
Feb 3, 2021	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 30, 2020	Supplement 7Labeling	Approved	Letter Label
Feb 15, 2020	Supplement 4Labeling · Standard review	Approved	Letter Label
Oct 4, 2019	Supplement 3Labeling · Standard review	Approved	Letter Label
Mar 11, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 17, 2018	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: BLA 761077
Drugs@FDA: Overview at FDA
Company: Amgen

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters