Teva Pharmaceutical Industries Ltd. has 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, according to Teva.
“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.”
Fremanezumab is an investigational therapy currently under review by the FDA as a quarterly or monthly injection for the preventive treatment of migraine in adults. It is a monoclonal antibody targeting the CGRP (calcitonin gene-related peptide) ligand.
With limited availability of preventive treatment options, fremanezumab represents a potential new option to address a significant unmet medical need.
(Source: Teva Pharmaceutical Industries Ltd.)