Novartis has announced that it will present 19 scientific abstracts at the 59th Annual Scientific Meeting of the American Headache Society (June 8-11, 2017, Boston, USA). This includes a new analysis from a pivotal 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. Erenumab is the first fully human monoclonal antibody therapy specifically designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, believed to play a critical role in mediating the incapacitating pain of migraine. CGRP levels rise during a migraine attack and normalize when the attack goes away.
"Migraine is one of the most debilitating neurological diseases, yet it is often misunderstood or ignored, despite devastating effects on patients’ personal and professional life,” said Vasant Narasimhan, global head drug development and chief medical officer for Novartis. “We are confident that with erenumab we are a step closer to offering a preventive therapy that is both efficacious and well-tolerated, ultimately helping patients to claim their lives back.”
Excessive use of acute pain-relief medication is common among people who suffer from migraine. Many patients experience low treatment satisfaction and enter a vicious cycle as they continue to take more and more acute migraine medications, while desperately trying to control their symptoms. Forty-one percent (274) of patients in the erenumab chronic migraine trial had recent history of medication overuse. Even in these difficult to treat patients, erenumab showed significant benefits. Both doses of erenumab (70mg and 140mg) significantly reduced monthly migraine days by an average of -6.6 days from baseline. These reductions were also statistically significant (p<0.001 in both doses) versus placebo (-3.5 days). Furthermore, days requiring acute pain-relief drugs were also reduced in both dosage arms (by 5.4 days for 70mg; 4.9 for 140mg; 2.1 for placebo, p <0.001).
Detailed results from the positive 6 month STRIVE study of erenumab 70mg and 140mg, and the positive 3 month ARISE study of erenumab 70mg will also be presented at the meeting. These data include both primary and secondary endpoints, evaluating the reduction in monthly migraine days and the percentage of patients who responded to erenumab. Results from STRIVE have been submitted for peer-reviewed publication.
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. Across the four placebo-controlled phase II and phase III clinical studies, more than 2,600 people have been exposed to erenumab. In addition, an ongoing extension trial is underway, evaluating erenumab in people with migraine for up to 5 years.
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.
Erenumab has been extensively studied in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention in more than 2,600 people, and a 5-year extension trial is currently underway. Following the initial phase II dose finding study, the efficacy of erenumab in migraine prevention has been shown in a phase II trial and two phase III trials. The safety profile of erenumab in these studies was comparable to placebo.