Alder BioPharma (NASDAQ:ALDR) reported new data from its Phase 3 trial of eptinezumab, a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP), for the prevention of migraines.
Nearly 60% of patients reported “much or very much” improvement in most bothersome symptoms and in overall migraine status following two infusions with the drug.
“A treatment that can provide the rapid, robust and sustained suppression of CGRP for migraine prevention as demonstrated in eptinezumab studies, while also improving patient-reported outcomes including symptom control, has the potential to provide a beneficial new option for patients with migraine, if approved,” Dr. Richard Lipton, director of the Albert Einstein College of Medicine’s Montefiore Headache Center, said in a statement.
In April 2019, the FDA accepted Alder’s BLA application for eptinezumab. If approved, eptinezumab will be the first quarterly infusion, anti-CGRP therapy for migraine prevention, with an expected commercial launch in the first quarter of 2020.
