Study of Ajovy in migraine published in Neurology journal.- Teva Pharma

Teva Pharmaceutical Industries announced that results from the 52-week, multicenter, randomized, double-blind, parallel group study evaluating monthly or quarterly Ajovy (fremanezumab-vfrm) injection in adults with chronic migraine (CM) or episodic migraine (EM), were published online ahead of print in Neurology. The primary objective of the study was to observe the long-term safety and tolerability of Ajovy over 52 weeks. The most common adverse events (AEs) leading to discontinuation (3-5 percent of patients) included injection site erythema, injection site rash, injection site swelling, injection site pruritis and increased weight. No clinically significant patterns of AEs or serious AEs were seen in the current study. No treatment-emergent, clinically significant laboratory findings were observed. In patients with CM or EM, the monthly number of migraine days decreased from baseline to month 12 (CM quarterly, –7.2 days; CM monthly, – 8.0 days; EM quarterly, –5.2 days; EM monthly, –5.1 days). Reductions in monthly number of headache days of at least moderate severity from baseline to month 12 were observed (CM quarterly, –6.4 days; CM monthly, –6.8 days; EM quarterly, –4.4; EM monthly, –4.2 days). Monthly number of headache days of any severity and monthly number of days of any acute headache medication use were also reduced across all treatment groups. More than half of patients with CM and approximately two-thirds of patients with EM had a miniumum of 50 percent reduction in monthly average number of migraine days from baseline to month 12. Specifically, the proportions of patients who had a minimum of 50 percent response rate continued to increase over time. Additionally, the degree of headache-related disability decreased for both CM and EM patients from baseline to month 12.