The U.S. Food and Drug Administration (FDA) has accepted for review the TEVA Pharmaceuticals (TEVA) Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.
“The progression of these clinical programs for fremanezumab underscores the potential to advance the treatment paradigm for a large portion of the migraine and headache patient community in need,” said Dr. Marcelo Bigal, M.D., Ph.D., Chief Scientific Officer and Head of Specialty R&D at Teva. “These two critical regulatory milestones, along with the initiation of our Phase II clinical program in post-traumatic headache, and our ongoing migraine program in patients who failed up to four classes of prior preventive treatment, reaffirm Teva’s leadership in migraine and headache disorders and highlight our mission to keep severely affected patients at the forefront of everything we do. We look forward to the potential to make fremanezumab commercially available for the prevention of migraine for patients in the U.S.next year.”
In order to bring this much-needed therapy to the migraine community, Teva 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. Regulatory action is anticipated by mid-2018:
The BLA 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 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.
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. Fast track designation is intended to facilitate development and expedite review of drugs to treat serious or life-threatening conditions. Additionally, Teva has also recently initiated a fremanezumab Phase II clinical program for the treatment of post-traumatic headache disorder.