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FDA Accepts BLA for Migraine Treatment, Grants Fast Track Designation to Development Program

DECEMBER 19, 2017
Mathew Shanley
Yesterday, Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA) for fremanzumab for the treatment of migraine. The potential therapy was also granted fast track designation for the prevention of cluster headache.

Cluster headache is a severe headache disorder that has been nicknamed “suicide headache” because the pain experienced by the patient is so severe that suicide is often contemplated or attempted as a form of relief. It occurs in clusters, as the name implies, and attacks can happen several times per day, lasting from 15 minutes to a few hours, but symptoms may not be experienced again for months. There are currently no FDA-approved therapies for cluster headaches, and it often takes years for a patient to be properly diagnosed. Some therapies, like high-flow oxygen, are used off-label to alleviate the pain.

The headaches are most commonly attributed to stress, dental problems, or sinus infections. Many patients are misdiagnosed with migraines.

“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 in a press release. “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.”

Fremanezumab is a fully-humanized monoclonal antibody which targets the CGRP ligand. Teva acquired a priority review voucher to expedite the review of the therapy, meaning that Teva will wait 6 months, rather than 10, to learn whether the FDA will approve the therapy. The PDUFA date for the drug is set for June 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), in which fremanezumab achieved statistically significant results across all endpoints. Additionally, the Phase 3 ENFORCE clinical research program is currently investigating the use of fremanezumab for the prevention of chronic and episodic cluster headache. Studies are expected to conclude by early 2019.

At present, cluster headache affects fewer than 1 in 1,000 adults, and the age of onset is most often between 20 and 40 years.

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