FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD

Disclosures

August 01, 2018

In This Article

Migraine: Aimovig (erenumab)

Indication: Indicated for the preventive treatment of migraines.

Mechanism: First human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor approved in the US. CGRP is a neuropeptide and is thought to be causally involved in migraine pathophysiology when released from trigeminal ganglia cells.

Dosage: 70 mg SC once monthly. Some patients may need 140 mg SC once monthly (administered as 2 consecutive 70-mg SC doses).

Approval was based on findings from the LIBERTY, ARISE, and STRIVE clinical trials. The LIBERTY trial studied difficult-to-treat patients (N=246) with episodic migraine who had failed 2 to 4 previous treatments. Patients treated with erenumab 140 mg had about a 3-fold higher odds of having their migraine days cut by half or more compared with placebo.

In the ARISE trial, 577 adults with episodic migraine were randomized to receive placebo or 70 mg erenumab (570 were included in efficacy analysis). Patients receiving erenumab experienced -2.9 days change in monthly migraine days, compared with -1.8 days for placebo (P<0.001). A ≥50% reduction in monthly migraine days was achieved by 39.7% (erenumab) and 29.5% (placebo) (P=0.010). Migraine-specific medication treatment days were reduced by -1.2 (erenumab) and -0.6 (placebo) days, a treatment difference of -0.6 (P=0.002).

The STRIVE clinical trial compared erenumab doses of 70 mg (N=317) or 140 mg (N=319) to placebo (N=319). The mean number of migraine days per month at baseline was 8.3 in the overall population; by months 4 through 6, the number of days was reduced by 3.2 in the 70-mg erenumab group and by 3.7 in the 140-mg erenumab group, as compared with 1.8 days in the placebo group (P<0.001 for each dose vs. placebo).

References:

  • Reuter U, Goadsby P, Lanteri-Minet M, et al. Efficacy and safety of erenumab in episodic migraine patients with 2-4 prior preventive treatment failures: Results from the Phase 3b LIBERTY study. Presented at the American Academy of Neurology 2018 Annual Meeting. Emerging Science Abstract 009. April 24, 2018. Los Angeles, CA. https://www.aan.com/PressRoom/Home/GetDigitalAsset/12692

  • Dodick DW, Ashina M, Brandes JL, et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. https://www.ncbi.nlm.nih.gov/pubmed/29471679

  • Goadsby PJ, Reuter U, Hallstrom Y, et al. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. https://www.ncbi.nlm.nih.gov/pubmed/29171821

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