Aimovig is the only investigational fully human monoclonal antibody, designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. These results are the first positive placebo-controlled data ever reported in an episodic patient population consisting entirely of those who have tried and failed two to four preventive medications due to lack of efficacy or intolerable side effects.
"We've purposely designed a clinical program for Aimovig that examined a broad spectrum of migraine patients, ranging from those who have never tried a preventive treatment to patients who have tried and failed such treatments," said
The safety, efficacy and tolerability of Aimovig have been assessed in more than 3,000 patients, including an ongoing open-label extension of up to five years in duration. Aimovig was the first investigational therapy targeting the CGRP pathway to receive
LIBERTY (NCT03096834) is a Phase 3b, multicenter, randomized 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of Aimovig in patients with episodic migraine (defined in the trial as four to 14 migraine days per month at baseline) who have failed up to four prior preventive treatments for migraine. In the study, 246 participants with episodic migraine who had two to four previous treatment failures were randomized to receive Aimovig 140 mg or placebo during the 12-week double-blind treatment phase. The primary endpoint was the percentage of patients with at least a 50 percent reduction of monthly migraine days from baseline over the last four weeks of the double-blind treatment phase of the study (weeks 9-12).1 The study includes an ongoing 52-week open-label extension study.
Secondary endpoints assessed during the same time period included: change from baseline in monthly migraine days, change from baseline in the number of monthly acute migraine-specific medication treatment days, and change from baseline in the MPFID physical impairment and impact on everyday activities domain scores. The MPFID is a scale developed to measure these two domains. The scale has been validated in line with FDA Patient Reported Outcomes Guidance.2 Percentages of patients with a 75 percent response rate and 100 percent response rate to erenumab were also assessed as secondary endpoints.
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. The safety, efficacy and tolerability of Aimovig has been assessed in more than 3,000 patients, including an ongoing open-label extension of up to five years in duration. 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
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
*The trade name Aimovig™ is provisionally approved for use by the
1 ClinicalTrials.gov A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies (LIBERTY). https://clinicaltrials.gov/ct2/show/NCT03096834. Accessed
2 Kawata AK et al. Psychometric Evaluation of a Novel Instrument Assessing the Impact of Migraine on Physical Functioning: The Migraine Physical Function Impact Diary. Headache. 2017; 57(9) 1385-1398.
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.
View original content with multimedia:http://www.prnewswire.com/news-releases/amgen-reports-aimovig-erenumab-met-all-primary-and-secondary-endpoints-in-unique-phase-3b-study-in-episodic-migraine-patients-who-have-failed-multiple-prior-preventive-treatments-300586199.html