Fremanezumab data in The Lancet demonstrate clinically meaningful reduction in monthly migraine days versus placebo for difficult-to-treat migraine. Teva

Teva Pharmaceutical Industries Ltd. announced that results from the Phase IIIb FOCUS study, which examined fremanezumab versus placebo in adult migraine patients who previously experienced inadequate responses to two to four classes of preventive treatments, were published online ahead of print in The Lancet.

The study found fremanezumab was superior versus placebo across all primary and secondary endpoints. The primary outcome measure of the trial was mean change from baseline in the monthly average number of migraine days during the 12-week treatment period following the first dose. Treatment resulted in statistically significant reductions in monthly average number of migraine days in participants who received either monthly or quarterly dosing with fremanezumab during the study.

Between November 2017 and July 2018, 838 patients with episodic (39 percent) or chronic (61 percent) migraine were randomized (1:1:1) by electronic interactive response technology (IRT) at 104 sites in 14 countries to placebo (n=279), quarterly fremanezumab (n=276), or monthly fremanezumab (n=283). Both patients with and without overuse of acute headache medication were included. Reductions from baseline in monthly days with migraine, moderate to severe headache, or use of acute headache medications were about 3.5 days (30 percentage points) greater with fremanezumab than with placebo (p<0.0001). the odds relative to placebo for achieving a ?50 percent reduction in migraine days as early as four weeks after starting study treatment were approximately six-fold higher with fremanezumab (p><0.0001). patients treated with fremanezumab had 3.1- to 3.8-day greater reductions in migraine days (from 9.4 to 17.1 days at baseline) across dosing and migraine classification subgroups than patients receiving placebo (p><0.0001), representing a therapeutic gain of 26 to 39 percentage points..>

The most common adverse reactions in the study were injection site reactions. Less than 1 percent of patients in the fremanezumab group experienced an adverse event leading to discontinuation. Patients with major comorbid diseases, including major cardiovascular disease, were excluded from participation in this study.

"Inadequate response" was defined as no clinically meaningful improvement after at least three months of therapy at a stable dose, per the treating physician�s judgement; discontinuation due to adverse events that made treatment intolerable; or the treatment was contraindicated or unsuitable for the preventive treatment of migraine for the patient. Documentation of prior failure to migraine preventive medication was generally based on the patient�s medical record, with the medication name, treatment duration, dose level and reason for discontinuation. If obtaining the medical record was not possible, the treating physician could provide an affidavit confirming prior treatment failures according to the protocol definition.

See-"Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial" Prof Michel D Ferrari, MD, Prof Hans Christoph Diener, MD, Xiaoping Ning, MD, Maja Galic, PhD, Joshua M Cohen, MD, Ronghua Yang, PhD et al. Published:August 16, 2019DOI:https://doi.org/10.1016/S0140-6736(19)31946-4