Teva Says FDA Accepts BLA For Fremanezumab - Quick Facts

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) said that the U.S. Food and Drug Administration has accepted for review the company's Biologics License Application or BLA for fremanezumab, an anti-calcitonin gene-related peptide or anti-CGRP monoclonal antibody for the preventive treatment of migraine.

Teva noted that the BLA includes data from the HALO clinical trial program, which enrolled more than 2,000 patients with episodic migraine or EM, and chronic migraine or CM, evaluating both quarterly and monthly dose regimens, in which fremanezumab achieved statistically significant results across all trial endpoints.

Results of the HALO CM trial were recently published in The New England Journal of Medicine. The most common adverse events reported in clinical trials include injection transient and mild site induration, erythema, and itching at the injection site.

In addition, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.

In order to bring this much-needed therapy to the migraine community, Teva said it acquired a priority review voucher to expedite the review of fremanezumab, which, if approved, would be a new preventive option for patients suffering from this debilitating disease. The company anticipates regulatory action by mid-2018.

According to Teva, Fremanezumab is also being investigated for the prevention of chronic and episodic cluster headache as part of the Phase III ENFORCE clinical research program, which has been granted fast track designation by the FDA. Trial participant recruitment is now underway and the studies are expected to conclude in early 2019.