Novartis today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for AMG 334 (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, erenumab is expected to be the first and only fully human monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, specifically designed for the prevention of migraine.
"Migraine is a serious, chronic neurological disease with a profound and limiting impact on patients' abilities to carry out everyday tasks," said Vas Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. "We look forward to continuing our longstanding history of redefining clinical practice in neurology by working with the FDA to bring erenumab to people suffering from migraine, and to subsequently reduce the overall burden of this debilitating disease."
Phase II and Phase III clinical studies of erenumab versus placebo have demonstrated a significant reduction in the number of migraine-affected days, acute medication over-use and disability, while improving quality of life for patients with episodic and chronic migraine. The safety profile of erenumab was similar to placebo in over 2,600 patients in the Phase II and Phase III studies assessing the prevention of migraine, and persistence rates were approximately 90 percent.
Erenumab will be jointly commercialized in the US by Amgen and Novartis.
AMG 334 (erenumab) is the only fully human monoclonal antibody specifically designed for the prevention of migraine that has been filed with the FDA. Erenumab specifically inhibits the receptor of the calcitonin gene-related peptide (CGRP), which is thought to play a causal role in migraine pathophysiology. Erenumab has been studied in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention.
Migraine is a distinct neurological disease. People with migraine lose a substantial portion of their lives to this illness, experiencing significant physical impairment, frequently accompanied by head pain, nausea, vomiting and meaningful disruption of daily activities. The World Health Organization ranks migraine as one of the most debilitating illnesses. For the approximately 10 million Americans whose migraine frequency or severity impacts daily activities, preventive medications may be an option. Approximately 3.5 million of these patients are currently on a preventive therapy, but up to 80 percent are non-adherent within one year. Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized, under-treated, and compounded by stigma and misunderstanding.