The drug is the first and only fully human monoclonal antibody of its kind, uniquely designed to specifically block the CGRP receptor, which plays a critical role in activation of migraine.
Novartis has announced new analyses across a spectrum of patients building a clear picture of the potential of AMG 334 (erenumab) for migraine prevention. The data add to the consistent efficacy and safety results to date, and cover quality of life, burden of disease and health economic topics relating to migraine.
A new analysis from a pivotal Phase II study shows erenumab reduced monthly migraine days in patients with chronic migraine for whom previous preventive treatments have failed. Erenumab is the first and only fully human monoclonal antibody designed to prevent migraine by targeting and blocking the calcitonin gene-related peptide (CGRP) receptor, believed to play a critical role in mediating the incapacitating pain of migraine.
Studies have shown that up to 80% of people with migraine discontinue preventive treatment within one year. In a pre-specified sub-analysis from the pivotal Phase II study, erenumab showed benefits even in people with chronic migraine who have tried and failed on two or more preventive treatments in the past. In these patients, erenumab cut the average number of migraine days by at least 5 days and up to a week per month, depending on treatment dose. Furthermore, this group also had three to four times higher odds of having their migraine days cut by 50% or more compared to placebo.
“These data highlight that erenumab has the potential to be a life-changing option for migraine patients with the highest unmet need – those who have tried and failed previous preventive treatments,” said Professor Messoud Ashina of the Danish Headache Center and Department of Neurology, University of Copenhagen, Denmark. “By significantly cutting migraine days, erenumab could help people get back much of their lives, which is what matters most to them.”
“We are excited about erenumab’s potential to prevent migraine for many sufferers, including those for whom previous preventive treatments have been ineffective or intolerable,” said Vas Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “The data presented at IHC add to the extensive and ever-growing body of evidence in support of the efficacy, safety and tolerability profile of erenumab.”Read More
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