Patients Experienced Sustained Reductions in Monthly Migraine Days and Consistent Safety Profile From Blinded Phase at 52 Weeks
THOUSAND OAKS, Calif., June 19, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive interim results from its open-label extension of the global Phase 2, double-blind, placebo-controlled study evaluating the safety and efficacy of AMG 334 for the prevention of episodic migraine. Patients who entered the open-label phase received AMG 334 70 mg monthly and experienced a sustained reduction in monthly migraine days at week 52. The data were presented at the 57th Annual Scientific Meeting of the American Headache Society (AHS) on June 19, 2015, in Washington, D.C.
At one year, patients receiving AMG 334 70 mg experienced an average of a -4.9-day reduction from a baseline of 8.7 mean monthly migraine days, regardless of treatment received during the blinded phase. The 50 percent responder rate (greater than 50 percent reduction in monthly migraine days) was 62 percent at 52 weeks. Additional responder rates were reported for the first time: at 52 weeks the 75 percent responder rate was 38 percent and the 100 percent responder rate was 19 percent.
"These long-term data further demonstrate that AMG 334 provided meaningful benefit to these patients with fewer migraine days and more days with the ability to participate in work and social activities each month," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The sustained safety and efficacy shown in this interim analysis adds to the growing body of evidence that reinforces the potential of AMG 334 for patients with this debilitating condition. We look forward to advancing the program to help fill an unmet need in migraine prevention."
The open-label portion of the Phase 2 study included 383 patients. All patients received AMG 334 70 mg starting at week 12 for up to 256 weeks. Safety and tolerability were evaluated monthly and this interim analysis includes data up to week 52. Additional efficacy endpoints included the change in monthly migraine-specific medication use days and patient-reported outcomes using the Migraine Disability Assessment (MIDAS) questionnaire.
Patients reported a nearly 50 percent reduction of monthly migraine-specific medication use days of -2 at 52 weeks, from a baseline of 4.3 days per month. In addition to clinical measures, patients self-reported the impact of headache and migraine on their daily activities. At one year, using the MIDAS tool, patients reported an improvement of approximately 12 days over the previous three months in their ability to function in work, home and social situations. According to the Migraine Research Foundation, migraine costs American employers more than $13 billion each year as a result of 113 million lost work days.
The safety and tolerability profile during the open-label phase was similar to that observed in the blinded phase of the study. The most commonly reported adverse events included fatigue, influenza, nasopharyngitis, arthralgia and back pain. No Grade 4 or 5 adverse events were reported. Serious adverse events were reported in 13 patients, one of which was deemed treatment-related. Less than 5 percent of patients discontinued the study during the open-label phase due to adverse events.
Migraine has been declared one of the top 10 most disabling conditions in the world, with more than 10 percent of the worldwide population suffering from the condition.1 More complex than just a headache, migraines involve incapacitating head pain and physical impairment, frequently accompanied by nausea, vomiting, and aura-related sound or other sensory disturbances.2 Migraine poses a significant burden to society, costing American employers more than $13 billion each year as a result of 113 million lost work days due to migraine.3 Migraine also has a tremendous impact on patients' everyday lives, including work productivity and social interactions.3,4 More than half of people living with migraine will go undiagnosed.5
About AMG 334
AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 targets the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that can cause incapacitating pain.
AMG 334 is currently under evaluation in several large global, randomized, double-blind, placebo-controlled studies to evaluate its safety and efficacy in migraine prevention.
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 biologics manufacturing 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 the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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1 Vos et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet. 2012 Dec-2013 Jan;30(9859):2163-2196.
2 National Institute for Neurological Disorders and Stroke. Headache: Hope Through Research. http://www.ninds.nih.gov/disorders/headache/detail_headache.htm. Accessed June 4, 2015.
3 Migraine Research Foundation. Migraine Fact Sheet. 2015. Available: http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed June 4, 2015.
4 Scher Al, Stewart WF, Ricci JA, Lipton RB. Factors associated with the onset and remission of chronic daily headache in a population-based study. Pain. 2003 Nov: 106(102:81-9).
5 National Headache Foundation. Migraine. Oct 2007. Available: http://www.headaches.org/2007/10/25/migraine/. Accessed June 4, 2015.
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