The US Food and Drug Administration (FDA) has accepted for review Teva Pharmaceutical Industries Ltd.'s (NYSE: TEVA; TASE: TEVA) Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. Teva submitted the application two months ago. 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, 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 US 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," Teva said.
Teva has stated in the past that fremanezumab is one of its most important specialty drug assets, and that it spent $150 million with a third part to obtain a priority review voucher for the product. Analysts estimate that the drug could reach peak annual sales of $2 billion, despite being in a competitive market. Teva received the drug through its acquisition of Labrys in 2014. It is meant to partially fill the hole left by the loss of exclusivity on Teva's flagship product, multiple sclerosis treatment Copaxone.
Published by Globes [online], Israel business news - www.globes-online.com - on December 18, 2017
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