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|May 23, 2018 8:00 a.m.|
|Teva Confirms September PDUFA Date for Fremanezumab|
“Our primary goal is to bring preventive treatment options to migraine
patients as quickly as possible,” said Hafrun Fridriksdottir, Executive
Vice President, Global R&D at Teva. “We are encouraged by the ongoing
communications with the
“We are incredibly excited to move this product forward in the review process and we are preparing to launch the product immediately when approved,” said Brendan O’Grady, Executive Vice President and Head of North America Commercial for Teva. “Migraine patients have waited years for new preventive treatments to enter the market.”
Fremanezumab is an investigational therapy currently under review by the
Fremanezumab is a monoclonal antibody targeting the CGRP (calcitonin gene-related peptide) ligand, currently being investigated as a preventive treatment for migraine. With limited availability of preventive treatment options, fremanezumab represents a potential new option to address a significant unmet medical need.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Fremanezumab, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 10-K for the
Teva Pharmaceutical Industries Ltd.