Novartis’s erenumab can prevent migraine

Novartis’s AMG 334 (erenumab) for migraine prevention in a second phase study 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.

Novartis said that studies show 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.

“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. Professor Ashina said that by significantly cutting migraine days, erenumab could help people get back much of their lives, which is what matters most to them.

Vas Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis, is happy to say that erenumab has potential to prevent migraine for many sufferers, including those for whom previous preventive treatments have been ineffective or intolerable. He said that 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.

Novartis also presented results from a safety study assessing erenumab 140 mg in a population of patients with stable angina, which showed that erenumab had no impact on cardiovascular function, addressing questions whether targeting the CGRP pathway could have consequences for those with pre-existing heart disease.

Erenumab is the first biologic anti-CGRP receptor drug to have received FDA and EMA regulatory filing acceptance. If approved, Novartis and Amgen will co-commercialize AMG 334 (erenumab) in the US. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in rest of world.