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Aimovig™ (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention
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"STRIVE is the first fully reported Phase 3 study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine," said
STRIVE enrolled 955 patients experiencing a mean baseline of 8.3 monthly migraine days, who were randomized to receive either placebo or subcutaneous Aimovig 140 mg or 70 mg once a month, for six months. Patients taking Aimovig at the higher dose experienced a significant 3.7-day reduction in monthly migraine days (3.2-day reduction with 70 mg, 1.8-day reduction with placebo; p<0.001 for both doses versus placebo). Fifty percent of patients taking Aimovig 140 mg had their migraine days cut by 50 percent or greater, representing a significantly higher likelihood of achieving this response compared to placebo (43.3 percent at 70 mg and 26.6 percent with placebo; odds ratios of 2.8 and 2.1 respectively for 140 mg and 70 mg; p<0.001 for both doses versus placebo). All STRIVE endpoints were assessed from baseline to the average of the last three months of the double-blind treatment phase of the study (months 4, 5, 6).
"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
Other secondary endpoint results from the Phase 3 study include:
- Patients taking Aimovig had significant reductions in the number of days per month using an acute or "rescue" migraine-specific medication compared to those taking placebo (1.6 days with 140 mg and 1.1 days with 70 mg group, compared to 0.2-day reduction with placebo; both doses p<0.001 versus placebo).
- Aimovig delivered clinically meaningful benefits by reducing the impact of migraine on patients' everyday activities, such as getting ready for the day, doing household chores or activities requiring concentration (5.9 points, 140 mg; 5.5 points, 70 mg; 3.3 points, placebo; p<0.001 for both doses versus placebo), as measured by the MPFID instrument, validated in line with
U.S. Food and Drug Administration( FDA) Patient Reported Outcomes (PRO) Guidance.1,2 In addition, scores measuring physical impairment, such as difficulty getting out of bed or activities requiring physical effort, were also significantly reduced with Aimovig (4.8 points, 140 mg; 4.2 points, 70 mg; 2.4 points, placebo; p<0.001 for both groups versus placebo).2
In the STRIVE study, the overall safety and tolerability profiles of Aimovig were similar to that of placebo. Adverse events occurring in greater than five percent of all treatment arms were nasopharyngitis and upper respiratory tract infection. More than 90 percent of patients in the Aimovig-treated arms completed the six-month study. Adverse events leading to discontinuation of treatment occurred in 2.2 percent of patients in either Aimovig treatment arm and in 2.5 percent of patients receiving placebo. STRIVE contributes to an extensive body of evidence in support of the efficacy, safety and tolerability profile of Aimovig, including four placebo-controlled Phase 2 and Phase 3 clinical studies involving more than 2,600 patients, as well as open-label extensions up to five years in duration.
Aimovig is the first and only investigational therapy targeting the CGRP pathway to have received
STRIVE (Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention, NCT02456740) is a global Phase 3, multicenter, randomized 24-week, double-blind, placebo-controlled study evaluating the safety and efficacy of Aimovig in episodic migraine (characterized in this study as ≥4 to <15 migraine days per month and <15 headache days per month on average across the three months before screening) prevention. In the study, 955 patients were randomized to receive once-monthly subcutaneous placebo, or Aimovig (70 mg or 140 mg) in a 1:1:1 ratio. Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline. The primary endpoint was change in mean monthly migraine days from baseline over the last three months of the double-blind treatment phase of the study (months 4, 5 and 6). Secondary study endpoints assessed at six months included reduction of at least 50 percent from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in both mean impact on everyday activities domain and mean physical impairment domain scores on the Migraine Physical Function Impact Diary (MPFID).
About Aimovig™ (erenumab)
Aimovig is the only treatment specifically designed to prevent migraine by blocking the CGRP receptor, which is associated with migraine activation. Aimovig has been studied in several large global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 2,600 patients have participated in the Aimovig clinical program across the four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions. Regulatory submissions have been filed in the U.S. and
People with frequent migraine may lose more than half their life to migraine days.3 Migraine robs individuals of time with their families, productivity at home and at work, and their livelihoods. Migraine sufferers endure debilitating pain, physical impairment, and live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.4
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
This news release contains forward-looking statements that are based on the current expectations and beliefs of
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*The trade name Aimovig™ is provisionally approved for use by the
1 Kawata, et al. Presented at 69th Annual Meeting of the
2 Roberts L, et al. Methods for Addressing Challenges for Evaluating Patient-Reported Outcomes in Clinical Trials of Prophylactic Treatments for Migraines. Presented at 58th Annual Meeting of the
3 Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventative therapy. Neurology. 2007; 68(5):343-9.
4 Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003;290:2443-54
5 Headache disorders - Fact sheets.
6 Marketscan data on file.
7 Hepp Z et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35(6):478-88.
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