The FDA has set a Prescription Drug User Fee Act target date for May 17, 2018.
Patients administered subcutaneous erenumab (Aimovig, Amgen/Novartis) in 70mg and 140mg doses experienced significantly reduced migraine frequency, effects of migraines on daily activities, and the use of acute-migraine specific medication over a 6-month period, according to new results published in the New England Journal of Medicine.
The treatment delivered clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints in the 6-month, phase 3 STRIVE study, per a joint statement from Amgen and Novartis.
“There is a clear unmet need for efficacious, innovative therapies for the prevention of migraine. Publication of these data underscores the significance of the CGRP receptor blocker Aimovig as potentially the first available treatment targeting a pathophysiologically relevant pathway for one of the most common causes of disability across the globe,” said Sean E Harper, MD, executive vice president of Research and Development at Amgen.
The STRIVE study enrolled 965 patients who experienced a mean baseline of 8.3 monthly migraine days. These patients were randomized to receive either placebo or subcutaneous erenumab 140mg or 70mg once per month for the duration of the 6-month study period.
The study’s primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month.
Patients taking the 140mg dose of erenumab experienced a 3.7-day reduction in monthly migraine days, a 3.2-day reduction with the 70mg dose, and a 1.8-day reduction with placebo; p<0.001 for both doses versus placebo.
The study met all secondary end points, the first of which was a 50% or greater reduction in mean migraine days per month. 50% of patients taking erenumab 140mg had their migraine days cut by 50% or greater, representing a significantly higher likelihood of achieving this response compared to placebo (43.3% at 70mg and 26.6% with placebo; OR 2.8 and 2.1 respectively for 140mg and 70mg; p<0.001 for both doses versus placebo).
Other secondary end points included the change in the number of days of use of acute migraine-specific medication, and change in scores on the physical-impairment and everyday-activities domains of the Migraine Physical Function Impact Diary.
Patients taking erenumab 140mg experienced 1.6-days reduction in the number of days using an acute or “rescue” migraine-specific medication. Moreover, patients taking 70mg erenumab experienced 1.1-days reduction, and the placebo group experienced a 0.2-day reduction; both doses p<0.001 versus placebo.
Erenumab reduced the effect of migraine on patients’ everyday activities, like getting ready for the day, doing household chores, or activities requiring concentration (5.9 points 140mg, 5.5 points 70mg, 3.3 points placebo; p<0.001). Additionally, scores measuring physical impairment, like difficulty getting out of bed, or activities requiring physical effort were also significantly reduced (4.8 points 140mg, 4.2 points 70mg, 2.4 points placebo; p<0.001 for both groups versus placebo).
The long-term safety and durability of the effect of erenumab requires further analysis, according to the study, which were supported by the Amgen and Novartis Neuroscience Collaboration.
Erenumab is the only treatment specifically designed to prevent migraine by blocking the CGRP receptor. It has been studied in several large global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy for the prevention of migraine.
Regulatory submissions have been filed in the US and Europe, and the US Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target date of May 17. 2018.