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JERUSALEM--(BUSINESS WIRE)--May 23, 2018--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today confirmed that the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for fremanezumab, an investigational therapy for the preventive treatment of migraine. The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab is set for September 16, 2018. There are no additional data requests from the FDA.

“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 FDA as we work to bring this important therapy to patients.”

“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.”

About Fremanezumab

Fremanezumab is an investigational therapy currently under review by the U.S. Food and Drug Administration (FDA) as a quarterly or monthly injection for the preventive treatment of migraine in adults.

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.