Teva Confirms September PDUFA Date for Fremanezumab

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.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2017 were $22.4 billion. For more information, visit www.tevapharm.com.

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