Novartis announced positive topline results from the global Phase III STRIVE study, evaluating the efficacy and safety of the fully human monoclonal antibody AMG 334 (erenumab) in episodic migraine prevention. Once-monthly subcutaneous AMG 334 was evaluated at 70mg and 140mg doses, with both doses meeting the study’s primary endpoint, demonstrating a statistically significant reduction from baseline in mean monthly migraine days at six months versus placebo. AMG 334 is specifically designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor that is believed to have a critical role in mediating the incapacitating pain of migraine.
“Migraine is one of the world’s most disabling diseases, and it remains under-recognized and under-treated. There is a significant need for effective, preventative treatments,” said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “We have now seen positive results with AMG 334 from two Phase III studies in episodic migraine and the Phase II study in chronic migraine, involving almost 2,200 people with migraine. We’re really excited that these new six-month data provide further evidence of the potential benefit AMG 334 could provide to people living with the debilitating symptoms of this disease.”
Patients enrolled in STRIVE were randomized to receive either placebo, or one of two AMG 334 doses, 70mg or 140mg, subcutaneously, once monthly, for six months. Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline. Over the last three months of the double-blind treatment phase, patients in the 70mg and 140mg AMG 334 treatment arms experienced a statistically significant 3.2-day and 3.7-day reduction from baseline in mean monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.
The safety profile of AMG 334 was comparable to placebo across both treatment arms over the six-month double-blind evaluation.The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and sinusitis.
Further analysis of the STRIVE data is ongoing. Positive results from ARISE, the first Phase III study of AMG 334 in episodic migraine prevention, and results from a Phase II study of AMG 334 in chronic migraine prevention, were announced earlier this year. These data will help support discussions with regulatory agencies, with filing anticipated in 2017.
More complex than just a headache, migraine has been declared by the World Health Organization to be one of the top 10 causes of years lived with disability for men and women.It has a profound and limiting impact on an individual’s ability to carry out everyday tasks and there is a real need for more effective preventative treatments to help reduce the number of monthly migraine days individuals experience. People with episodic migraine experience up to 14 migraine days each month.
AMG 334 is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen has commercialization rights in the U.S., Canada and Japan, and Novartis has commercialization rights in Europe and the rest of the world.