The FOCUS phase 3b study evaluated the long-term efficacy of fremanezumab in patients with chronic or episodic migraine (CM/EM) and prior documented inadequate response to 2-4 preventive treatment classes during 12-week double-blind period (DBP) and open-label extension (OLE).

Following 28-day baseline period, patients were randomised (1:1:1) to quarterly or monthly fremanezumab or placebo for DBP. Patients completing DBP entered OLE, where all patients received treatment with monthly fremanezumab. Outcomes are summarised by DBP group.

During DBP, least squares mean changes in monthly migraine days (MMD) in placebo, quarterly, and monthly fremanezumab groups, respectively, were –0.8, –3.9, and –4.5 for CM patients (n=509) and –0.6,

–3.7, and –3.8 for EM patients (n=328; P<0.0001 vs placebo); during OLE, mean MMD changes were –5.3,

–5.1, and –5.8 for CM patients (n=493) and –3.9, –5.1, and –5.1 for EM patients (n=313). Reductions were also observed for CM and EM patients in monthly headache days of at least moderate severity during DBP and increased during OLE. In placebo, quarterly, and monthly fremanezumab groups, respectively, for DBP, ≥50% reduction in MMD were 8%, 27%, and 29% for CM patients and 10%, 47%, and 43% for EM patients (P<0.0001 vs placebo) and for OLE, were 31%, 35%, and 40% for CM patients and 49%, 63%, and 56% for EM patients.

Fremanezumab demonstrated long-term efficacy in CM and EM patients with prior inadequate response to multiple preventive classes.