Novartis announced positive first results from the global phase II 20120295 study, investigating the efficacy and safety of the fully human monoclonal antibody AMG 334 (erenumab) in chronic migraine prevention. The study evaluated AMG 334 at two doses, 70mg and 140mg, administered subcutaneously once a month, with both doses meeting the study’s primary endpoint of a statistically significant reduction in the number of monthly migraine days versus placebo.
“Patients with chronic migraine live with the debilitating and disabling symptoms of this disease for 15 or more days each month, significantly impacting their everyday life and ability to work,” said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. “We are delighted that with this positive outcome, we are one step closer to providing patients with a much-needed new treatment option to prevent chronic migraine. Also, we are looking forward to assessing the benefit of AMG 334 in two ongoing phase III studies in episodic migraine, with initial data from these studies expected later this year.”
Overall, patients had a mean baseline of 18 migraine days per month. Patients randomized to the 70mg and 140mg dose groups experienced a mean 6.6-day reduction from baseline in monthly migraine days in both groups. The results were statistically significant compared with 4.2 days observed in the placebo group.
The safety and tolerability profile of AMG 334 was similar to placebo in both treatment groups. No adverse event was reported in greater than five percent of patients treated with AMG 334; the most commonly reported adverse events included injection site pain, infection of the upper respiratory tract and nausea.
Additional analyses of these data are ongoing and are expected to be submitted to a future medical meeting and for publication.
More complex than a headache, migraine is the most prevalent of all neurological disorders, affecting more than 10% of the worldwide population. Migraine has a profound and limiting impact on patients’ abilities to carry out everyday tasks and as a result it is classed as the sixth leading cause of years lived with disability. Chronic migraine patients experience the greatest impact on daily activities and quality of life, with at least 15 headache days per month, of which eight or more are migraines, for more than three months.
AMG 334 is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and rest of world.