The early onset of efficacy of Teva Pharmaceutical’s fremanezumab may have the potential to improve patient compliance and clinical outcomes, according to results from a phase 3 trial published in the journal Headache.
The double‐blind phase III study enrolled 1,130 patients who were randomized 1:1:1 to receive subcutaneous injections of fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (675 mg at baseline, 225 mg at weeks 4 and 8), or placebo at each time point. This study included secondary, exploratory, and post hoc analyses of the primary trial, evaluating the change in headache days of at least moderate severity or migraine days during the first 4 weeks of the trial.
During the 4‐week period after the first dose, the mean number of monthly headache days of at least moderate severity was reduced for the all‐fremanezumab group (mean reduction −4.6 days compared with the placebo group mean reduction −2.3 days). Treatment effects were observed at Week 1 for the all‐fremanezumab group (−1.1 days versus placebo at −0.5 days), with separation from placebo by Day 2. Similar effects were observed for the monthly average number of migraine days and mean number of monthly headache hours.
About fremanezumabFremanezumab is a calcitonin gene-related peptide antagonist. It has been approved by the FDA as Ajovy for the preventive treatment of migraine in adults.