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|Amgen And Novartis Present New Data Demonstrating Long-Term Efficacy, Safety And Tolerability Of Aimovig™ (erenumab-aooe) In Patients With Chronic And Episodic Migraine|
In the one-year OLE study in chronic migraine, the primary and secondary outcome measures of the study were long-term safety and efficacy, respectively.1 The safety results after one year were consistent with the established safety profile of Aimovig in previous studies. The most frequent adverse events (AEs) greater than 2.0 per 100-subject-years were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, arthralgia and migraine. In the double-blind treatment phase, no differences were observed in the safety events between Aimovig and placebo.
The efficacy data showed sustained benefits up to one year. Patients taking Aimovig 140 mg and 70 mg (based on last dose received) achieved reductions of average monthly migraine days of 10.5 and 8.5 days, respectively, compared to a baseline of 18.1 (at the time of enrollment into the placebo-controlled study, after one year of treatment). Patients treated with Aimovig experienced reductions in monthly migraine days of:
"These data showing sustained efficacy and consistent safety and tolerability of Aimovig over an extended period of time are important for migraine patients and their clinicians to know," said
The five-year OLE study in episodic migraine is assessing the long-term safety and tolerability of Aimovig.2 The results at the three-year interim data analysis showed Aimovig had a safety profile consistent with the spectrum and rate of AEs seen in shorter-term placebo-controlled studies, no new AEs and no new causally-related serious AEs. The most frequent AEs were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, influenza and back pain. There was no increase in cardiovascular events over time and no meaningful changes in systolic/diastolic blood pressure or heart rate up to the ~3.2-year follow-up.2
"On the heels of the recent
Additional data in patients with chronic migraine are being presented at the AHS meeting, including long-term efficacy of Aimovig in patients with overuse of acute medication, long-term efficacy of Aimovig in patients who failed prior prophylactic treatment, and efficacy of Aimovig at varying dosage strengths in the Phase 3 STRIVE study.
About the Open-Label Extension Study in Chronic Migraine
The primary outcome measure of the study was long-term safety. The secondary outcome measure was efficacy, as determined by four measures: change from baseline to week 52 in monthly migraine days (MMD), monthly acute migraine-specific medication days, monthly cumulative hours of headache, and proportion of patients achieving at least a 50 percent reduction in MMD.
About the Open-Label Extension Study in Episodic Migraine
Safety and efficacy data after four and five years of treatment will be reported in the future.
About Aimovig™ (erenumab-aooe)
U.S. Aimovig Indication
Aimovig is indicated for the preventive treatment of migraine in adults.
U.S. Aimovig Important Safety Information
About Amgen and Novartis Neuroscience Collaboration
Forward Looking Statements
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