BACKGROUND: Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) 
selectively targets the calcitonin gene-related peptide and has proven efficacy 
for the preventive treatment of migraine. In this study, we evaluated the 
long-term efficacy, safety, and tolerability of monthly and quarterly 
fremanezumab.
METHODS: Episodic migraine and chronic migraine patients completing the 12-week 
double-blind period of the FOCUS trial entered the 12-week open-label extension 
and received 3 monthly doses of fremanezumab (225 mg). Changes from baseline in 
monthly migraine days, monthly headache days of at least moderate severity, days 
of acute headache medication use, days with photophobia/phonophobia, days with 
nausea or vomiting, disability scores, and proportion of patients achieving 
a ≥50% or  ≥75% reduction in monthly migraine days were evaluated.
RESULTS: Of the 807 patients who completed the 12-week double-blind treatment 
period and entered the open-label extension, 772 patients completed the study. 
In the placebo, quarterly fremanezumab, and monthly fremanezumab dosing 
regimens, respectively, patients had fewer average monthly migraine days (mean 
[standard deviation] change from baseline: - 4.7 [5.4]; - 5.1 [4.7]; - 5.5 
[5.0]), monthly headache days of at least moderate severity (- 4.5 [5.0]; - 4.8 
[4.5]; - 5.2 [4.9]), days per month of acute headache medication use (- 4.3 
[5.2]; - 4.9 [4.6]; - 4.8 [4.9]), days with photophobia/phonophobia (- 3.1 
[5.3]; - 3.4 [5.3]; - 4.0 [5.2]), and days with nausea or vomiting (- 2.3 [4.6]; 
- 3.1 [4.5]; - 3.0 [4.4]). During the 12-week open-label extension, 38%, 45%, 
and 46% of patients, respectively, achieved a ≥50% reduction and 16%, 15%, and 
20%, respectively, achieved a ≥75% reduction in monthly migraine days. 
Disability scores were substantially improved in all 3 treatment groups. There 
were low rates of adverse events leading to discontinuation (<1%).
CONCLUSION: Fremanezumab demonstrated sustained efficacy up to 6 months and was 
well tolerated in patients with episodic migraine or chronic migraine and 
documented inadequate response to multiple migraine preventive medication 
classes.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03308968 (FOCUS).