Drug Update · Neurology

FDA Approves erenumab for Migraine: 43.3% ≥50% MMD Responders

July 10, 2026

Approved indication

Preventive treatment of migraine in adults

Recommended dose

70 mg once monthly; some patients may benefit from 140 mg once monthly

Primary efficacy (Study 1)

Mean MMD change −3.2 (AIMOVIG 70 mg) vs −1.8 (placebo); difference −1.4 [5]

Responder rate (Study 1)

≥50% MMD responders 43.3% (AIMOVIG 70 mg) vs 26.6% (placebo); difference 16.7% [5]

FDA approval date / label effective date

Original approval 2018-05-17; label effective date 2025-06-19 [5]

Clinical Perspective

In pivotal trials that supported approval, erenumab was studied in adults with a history of migraine (episodic migraine defined as 4–14 migraine days per month in the episodic migraine studies) and excluded certain populations such as patients with medication overuse headache in at least one episodic-migraine study; these eligibility criteria should be considered when applying trial results to practice. What are the comparative efficacy and safety differences between erenumab, fremanezumab, and galcanezumab in head-to-head studies and real-world practice?

Dr. Vikram Patel · Neurology

The FDA approved erenumab (AIMOVIG) for the preventive treatment of migraine in adults on 2018-05-17 based on randomized placebo-controlled studies, including Episodic Migraine Study 1, in which the primary endpoint (change from baseline in mean monthly migraine days over months 4 to 6) was −3.2 days with AIMOVIG 70 mg (consult current prescribing information for full dosing guidance) versus −1.8 days with placebo, a difference of −1.4 days ^[5].

Clinical Context

Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway are available for migraine prevention and have been used since 2018 ^[5]. The preventive-treatment class includes agents such as erenumab, fremanezumab, and galcanezumab as referenced in recent observational and overview reports ^[1]^[2]. Erenumab is a human monoclonal antibody that binds to the CGRP receptor and antagonizes CGRP receptor function ^[5].

Key Findings

In Episodic Migraine Study 1, the primary endpoint (change from baseline in mean monthly migraine days over months 4 to 6) was −3.2 days with AIMOVIG 70 mg (consult current prescribing information for full dosing guidance) versus −1.8 days with placebo, a difference of −1.4 days ^[5].
Episodic Migraine Study 1 randomized 955 patients to AIMOVIG 70 mg (N = 317), AIMOVIG 140 mg (N = 319), or placebo (N = 319) in a 6-month trial ^[5].
Episodic Migraine Study 1 reported ≥ 50% MMD responders of 43.3% with AIMOVIG 70 mg versus 26.6% with placebo; the difference from placebo for the 70 mg group was 16.7% ^[5].
Study 1 reported AIMOVIG treatment produced greater reductions from baseline in mean monthly MPFID everyday activity scores (difference from placebo: −2.2 for AIMOVIG 70 mg) and in mean monthly MPFID physical impairment scores (difference from placebo: −1.9 for AIMOVIG 70 mg) averaged over months 4 to 6 ^[5].
Randomized, double-blind, placebo-controlled trials formed the basis for efficacy claims in episodic and chronic migraine populations in the prescribing information ^[5].

Safety & Tolerability

Safety information was not available in the provided source excerpts.

Study Design

The efficacy of AIMOVIG was evaluated in randomized, multi-center, double-blind, placebo-controlled studies, including Episodic Migraine Study 1, a 6-month trial that randomized a total of 955 patients to AIMOVIG 70 mg (N = 317), AIMOVIG 140 mg (N = 319), or placebo (N = 319) with the primary efficacy endpoint defined as change from baseline in mean monthly migraine days over months 4 to 6 ^[5]. (consult current prescribing information for full dosing guidance)

FAQ

Q1 What is erenumab (AIMOVIG) approved for?

A1 AIMOVIG (erenumab-aooe) is indicated for the preventive treatment of migraine in adults. The FDA prescribing information states the indication explicitly as preventive treatment of migraine in adults and describes efficacy evidence from randomized, double-blind, placebo-controlled studies in episodic and chronic migraine populations. (consult current prescribing information for full dosing guidance)

Q2 How does erenumab (AIMOVIG) work?

A2 Erenumab-aooe is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function, as described in the prescribing information. The labeling presents this mechanism of action statement in the Mechanism of Action section of the AIMOVIG prescribing information. (consult current prescribing information for full dosing guidance)

Q3 What is the recommended dose of erenumab (AIMOVIG)?

A3 The recommended dosage of AIMOVIG is 70 mg injected subcutaneously once monthly, and the prescribing information notes that some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly. Administration instructions in the label include subcutaneous injection in the abdomen, thigh, or upper arm and guidance on preparation and self-administration using the single-dose prefilled autoinjector or syringe. (consult current prescribing information for full dosing guidance)

Q4 What are the most common side effects of erenumab (AIMOVIG)?

A4 Safety details and adverse event listings were not available in the provided source excerpts. The prescribing information excerpt included in the provided sources did not present a list of common adverse reactions in the supplied text. (consult current prescribing information for full dosing guidance)

FDA Approves erenumab for Migraine: 43.3% ≥50% MMD Responders

FDA Approves erenumab for Migraine: 43.3% ≥50% MMD Responders

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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