Novartis presented 18 scientific abstracts at the 59th Annual Scientific Meeting of the American Headache Society in early June of this year.
Included was new analysis from a study highlighting the efficacy of AMG 334 (erenumab) in patients with 15 or more headache days a month (chronic migraine) and a recent history of acute migraine medication overuse.
Also being presented at AHS are detailed results of STRIVE and ARISE, two Phase III studies of erenumab in people with 4 to 14 migraine days per month.
The first fully human monoclonal antibody therapy, erenumab is designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, which is believed to be efficient in targeting migraine pain, as CGRP levels rise during a migraine attack.
“Migraine is one of the most debilitating neurological diseases in Ireland, yet it is often misunderstood or ignored, despite devastating effects on patients’ personal and professional life,” stated Simon Schmidt, Chief Scientific officer for Novartis Ireland.
Migraine sufferers commonly rely on an excessive use of acute pain-relief, though many find that they are ill effective, thus entering into a vicious cycle whereby they take increasing levels of acute migraine medications, in an effort to control their symptoms. Forty one percent (274) of patients in the erenumab chronic migraine trial admitted to recent history of medication overuse.
Even in difficult to treat patients, the drug is claimed to have shown significant benefits.
Erenumab is currently being investigated for migraine prevention and these data support the first regulatory filing packages submitted in the United States and European Union for a CGRP inhibitor in migraine prevention.
Four placebo-controlled Phase II and Phase III clinical studies have seen over 2,600 people being exposed to erenumab. An ongoing extension trial evaluating erenumab in people with migraine for up to 5 years is currently also underway.
Novartis and Amgen will co-commercialise erenumab in the US, Amgen has exclusive commercialisation rights to the drug in Japan while Novartis has exclusive rights to commercialise in rest of world.