NEJM publishes data on Teva's phase 3 trial of Fremanezumab
Teva Pharmaceutical Industries announced the publication of data from the pivotal Phase III HALO study evaluating the efficacy, safety and tolerability of two subcutaneous dose regimens of fremanezumab for the preventive treatment of chronic migraine. These data were published online today by the New England Journal of Medicine and will appear in a subsequent print issue. The article, "Fremanezumab for the Preventive Treatment of Chronic Migraine," reports results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III study that evaluated monthly and quarterly doses of fremanezumab versus placebo for the preventive treatment of chronic migraine in 1,130 patients. These findings, along with findings from the HALO Phase III study evaluating the efficacy, safety and tolerability of two subcutaneous dose regimens of fremanezumab for the preventive treatment of episodic migraine, were included in the Biologics License Application for fremanezumab that Teva submitted to the U.S. Food and Drug Administration in October. The most common adverse events reported in clinical trials include injection site induration, erythema, and pruritis.