Amgen To Highlight Extensive Long-Term Safety And Efficacy Data Of Aimovig® (erenumab-aooe) Across The Spectrum Of Migraine At AAN Annual Meeting
THOUSAND OAKS, Calif., May 2, 2019 /PRNewswire/ -- Amgen(NASDAQ:AMGN) today announced that it will present new long-term data of Aimovig® (erenumab-aooe) across the migraine spectrum at the 2019 American Academy of Neurology (AAN) Annual Meeting in Philadelphia. Data from a one-year open-label extension (OLE) trial following a three-month double blind study in patients with chronic migraine (15 or more headache days per month) showed sustained efficacy and safety in this patient population, including a potential for conversion to episodic migraine (4-14 headache days a month). Additionally, one-year results of the Phase 3 STRIVE study reinforced the sustained efficacy and safety profile of Aimovig in patients with episodic migraine, including patients who had tried and failed prior preventive treatments.
Migraine is a highly debilitating disease that has a profound and limiting impact on peoples' lives, including time spent with family and friends, or at work.2,3 Aimovig, co-commercialized in the U.S. by Amgen and Novartis, is the first and only FDA-approved treatment that prevents migraine by targeting the calcitonin gene-related peptide (CGRP) receptor. It is self-administered once monthly via the SureClick® autoinjector, does not require a loading dose and is easy to use.1
"We are pleased to see new efficacy and safety results for Aimovig, which was the first CGRP therapy approved by the FDA in May 2018 and has the longest post-approval treatment experience of any CGRP therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These long-term results further establish the benefit of Aimovig across the spectrum of patients with migraine."
Data in Chronic Migraine
"Millions of people with chronic migraine spend at least half of each month living with the debilitating symptoms of this disease," said Stewart Tepper, M.D., Neurology Professor at the Geisel School of Medicine at Dartmouth Medical School. "We are encouraged by these new findings, which show that long-term erenumab treatment increases the likelihood that a patient with chronic migraine will experience a meaningful reduction in migraine days."
Further data from the study evaluating the long-term efficacy and safety results of Aimovig in patients with chronic migraine during open-label treatment are being presented at AAN.
Data in Episodic Migraine
At week 52, patients receiving Aimovig 70 mg or 140 mg from week 24 onward had an average of 4.2 and 4.6 fewer MMD, respectively, compared to study baseline (8.3 MMD). They also continued to experience improvements during the ATP (1.1 and 1.8 fewer MMD, respectively). In addition, an analysis of responder rates from baseline showed more than six out of 10 patients on either dose of Aimovig had 50 percent fewer MMD; around four out of 10 had 75 percent fewer MMD; and one in five were migraine-free at week 52.
Additional data from STRIVE and the OLE phase of the LIBERTY study in patients taking Aimovig with episodic migraine who had failed prior preventive treatments are being presented at AAN.
About the Open-Label Extension Study in Chronic Migraine
Proportions of episodic migraine converters/nonconverters based on observed data were summarized throughout the OLE (overall population) and by last dose received (70 mg or 140 mg). Efficacy data were collected at weeks 1–12, 21–24, 37–40, and 49–52; endpoints included change from parent study baseline in monthly migraine days (MMD) and proportion of patients with ≥50 percent reduction from parent study baseline in MMD.
At week-24 (ATP baseline), 845 patients were re-randomized (1:1) to Aimovig 70 mg or 140 mg for the subsequent 28-week dose-blinded ATP. Assessments included MMD; monthly acute migraine-specific medication days (MSMD); proportion of patients achieving a ≥50 percent, ≥75 percent, and 100 percent reduction in MMD (responder rates: RR); and safety.
About Aimovig® (erenumab-aooe)
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig® and initiate appropriate therapy.
Adverse Reactions: The most common adverse reactions in clinical studies (≥ 3% of Aimovig®-treated patients and more often than placebo) were injection site reactions and constipation.
Please see Aimovig® full Prescribing Information.
About Amgen and Novartis Neuroscience Collaboration
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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