FDA Drug Approvals: Neurology — Year in Review 2018

Mary L Windle, PharmD

Disclosures

January 15, 2019

New Drugs for Migraine

Aimovig (erenumab)

Erenumab is a human monoclonal antibody that binds to and antagonizes the calcitonin gene-related peptide (CGRP) receptor. Inhibiting the CGRP pathway is a new method to prevent migraine headaches. CGRP is a potent vasodilator and is a key neuropeptide that is central to migraine pathophysiology. Erenumab is available for subcutaneous injection either by prefilled autoinjector or syringe as a single-dose, once-monthly injection.

Approval for erenumab was based on three randomized, controlled trials: two trials (STRIVE and ARISE) for patients with episodic migraine (4-14 migraine days/month) and one trial in patients with chronic migraine (≥15 headache days/month).

In the first of two trials for episodic migraine, STRIVE (n=955) determined the change in monthly migraine days over a 4- to 6-month treatment period. The trial showed reductions in monthly migraine days for both treatment groups (70 mg or 140 mg monthly) compared with placebo at 4-6 months (P<.001). The average number of migraine days per month at baseline was 8.3 overall and decreased by 3.2, 3.7, and 1.8 in the 70-mg group, 140-mg group, and placebo group, respectively. (N Engl J Med. 2017 Nov 30;377(22):2123-2132)

Study 2, the ARISE trial (n=577), similarly showed statistically significant reductions in monthly migraine days for patients receiving erenumab 70 mg compared with placebo at 3 months (P<.001). (Cephalalgia. 2018 May;38(6):1026-1037)

In the trial for chronic migraine, study 3 (n=667) randomized patients to receive either erenumab at 70 mg or 140 mg, or placebo, as a monthly subcutaneous injection. The study showed the same decrease in monthly migraine days from baseline in both treatment groups at 3 months, a significant decrease compared with placebo (-6.6 vs -4.2; P<.001). (Lancet Neurol. 2017 Jun;16(6):425-434)

Ajovy (fremanezumab)

Fremanezumab, the second calcitonin gene-related peptide (CGRP) inhibitor approved for migraine prevention, is administered as a once-monthly or once-quarterly subcutaneous injection. Approval for fremanezumab was based on two randomized, 3-month, controlled trials: one trial in patients with episodic migraine (HALO-EM) and one trial in patients with chronic migraine (HALO-CM).

In HALO-EM (n=875), patients were randomized to receive subcutaneous injections of either fremanezumab 675 mg quarterly, fremanezumab 225 mg monthly, or placebo monthly. The change from baseline monthly migraine days in the 225-mg monthly group, 675-mg quarterly group, and placebo group was -3.7, -3.4, and -2.2, respectively. Both treatment groups demonstrated statistically significant improvements for efficacy endpoints compared with placebo (P<.001). (JAMA. 2018 May 15;319(19):1999-2008)

In HALO-CM (n=1130), patients were randomized to receive subcutaneous injections of either fremanezumab 675 mg starting dose followed by 225 mg monthly, fremanezumab 675 mg quarterly, or placebo monthly, over 3 months. Both monthly and quarterly regimens of fremanezumab showed statistically significant improvements compared with placebo in the primary endpoint of change from baseline in monthly number of headache days of at least moderate severity (P<.001). (N Engl J Med. 2017 Nov 30;377(22):2113-2122)

Emgality (galcanezumab)

The third calcitonin gene-related peptide (CGRP) inhibitor approved for migraine prevention in 2018, galcanezumab, is administered as a once-monthly subcutaneous injection after an initial loading dose.

Approval for galcanezumab was based on two 6-month trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2). The two trials included more than 1700 patients with episodic migraine. Mean monthly migraine headache days were reduced by 4.3-4.7 and 4.2-4.6 days by galcanezumab 120 mg and 240 mg, respectively, and 2.3-2.8 days by placebo (both P<.001). (JAMA Neurol. 2018 Sep 1;75(9):1080-1088; Cephalalgia. 2018 Jul;38(8):1442-1454)

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