FDA approves new drug for migraine prevention

Naveed Saleh, MD, MS, for MDLinx | October 05, 2018

The US Food and Drug Administration (FDA) recently approved fremanezumab for the prevention of migraine in adults. Fremanezumab is the second calcitonin gene-related peptide (CGRP) blocker approved for this indication, following the approval of erenumab as the first-in-class agent in May 2018.  

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In patients with episodic migraine and those with chronic migraine, treatment with fremanezumab increased the number of headache-free days, with more normal functional performance.

The approval of fremanezumab, administered as a subcutaneous injection either 675 mg quarterly or 225 mg monthly, is based on the results of several clinical trials in which researchers observed clinical benefit, including a recently published study in Neurology.

“Fremanezumab, formerly known as TEV-48125, is a fully humanized immunoglobulin G2a monoclonal antibody that potently and selectively binds to CGRP, thereby preventing its binding to receptors,” wrote the authors, led by Juliana VanderPluym, MD, Mayo Clinic, Phoenix, AZ.

To evaluate the effect of fremanezumab on functional performance during headache-free days, researchers performed a post hoc analysis of data from prior phase 2 and 3 trials of the safety and efficacy of fremanezumab in 1,170 patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM).

“In each study, 2 doses of fremanezumab were administered as 4 subcutaneous injections once a month for 3 months: monthly 225- or 675-mg fremanezumab in the HFEM study and 675-mg (1 initial loading dose) followed by monthly 225- or 900-mg fremanezumab in the CM study,” wrote the authors.

Patients in the HFEM and CM trials who were administered fremanezumab (225- or 675-mg) reported more headache-free days with normal functional performance compared with those taking placebo, with respect to work, school, and household chore performance, and energy and concentration levels. Researchers observed similar results in fremanezumab-treated patients in the CM trial who were administered 900-mg doses.

The team found that fremanezumab was safe and well tolerated, with no notable adverse events (AEs), other than injection-site pain, itching, and possible infection. Most reactions manifested within hours to 1 month following drug administration and were mild-to-moderate in severity; however, some led to discontinuation and required treatment with corticosteroids. Fremanezumab is contraindicated in patients who are hypersensitive to the drug or its expedients.

The authors acknowledged that one potential limitation of the current study was that patients may have become unblinded due to differences in AEs between the active and placebo interventions, which may have affected reporting. Due to the low rate of AE occurrence in the HFEM and CM trials, however, it was unlikely that unblinding due to AE differences had a significant impact on the results.

“There was an increased number of headache-free days with normal functional performance on all measures for the patients with EM and some measures for patients with CM in the fremanezumab-treated groups,” concluded the researchers.

The current costs of fremanezumab are $575 for the monthly dose and $1,725 for the quarterly dose.

The study was funded by Teva Pharmaceutical Industries.

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