Teva Pharmaceutical Industries Ltd., announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for fremanezumab, an anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of episodic and chronic migraine in adults. Fremanezumab is a quarterly or monthly injection that may be administered by a healthcare professional, or self-administered by the patient.
“The successful filing of the MAA for fremanezumab with the EMA builds on the momentum of the global fremanezumab program, following acceptance of the Biologics License Application with the U.S. Food and Drug Administration,” said Ernesto Aycardi, MD, Vice President Head of Clinical Trial Execution, Data Sciences and Biometrics & Clinical Pharmacology at Teva. “With limited availability of preventive therapy options that target the underlying biological mechanisms of migraine, the MAA acceptance represents a major step toward advancing the treatment paradigm for the migraine community. These two significant regulatory milestones in the migraine indication, combined with our clinical development programs for fremanezumab in cluster headache and post-traumatic headache, highlight Teva’s commitment to patients worldwide with these debilitating conditions.”
The MAA includes data from the HALO clinical trial program, which enrolled more than 2,000 patients with episodic migraine (EM) and chronic migraine (CM), evaluating both quarterly and monthly dosing regimens, in which fremanezumab achieved statistically significant results across all trial endpoints. The most common adverse events reported in clinical trials include injection site pain, induration, and erythema.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies to compare the safety, tolerability, and efficacy of four dose regimens of subcutaneous fremanezumab compared to placebo in adults with episodic and chronic migraine. The studies consisted of a screening visit, a 28-day run-in period, and a 12-week (84-day) treatment period, including a final evaluation at week 12 (end-of-treatment [EOT] visit, four weeks [28 days] after the final dose of study drug).
• In the EM study, 875 patients were enrolled (294, 291, and 290 patients in the placebo, quarterly, and monthly dose groups, respectively). Patients were randomized in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 225 mg for three months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the EM study was the mean change from baseline (28-day run-in period) in the monthly average number of migraine days during the 12-week period after the first dose of fremanezumab.
• In the CM study, 1,130 patients were randomized (around 376 patients per treatment group). Patients were randomized in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 675 mg at initiation followed by monthly 225 mg for two months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the CM study was the mean change from baseline (28-day run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of fremanezumab.