Amgen Announces Approval Of Aimovig® (Erenumab) In Japan For The Suppression Of Onset Of Migraine Attacks In Adults
"Today's approval further strengthens
Aimovig's approval in
"We were impressed by the Japanese Phase III study (20170609) that showed patients treated with Aimovig saw a reduction from baseline in their monthly migraine days," said
Migraine is a debilitating neurological condition and can have significant impact on many areas of a person's life.1,7 Although approximately 8.4 million people in
"Migraine is a serious neurological disease, yet is poorly understood in
Aimovig (erenumab-aooe) was approved as a preventive treatment for migraine in adults in
About the 20120309 Study
The 20120309 study is a Phase II, randomized, placebo-controlled study comprised of a six-month (24 weeks) DBTP that evaluated the safety and efficacy of erenumab for the prevention of episodic migraine in adult Japanese patients. Participants were randomized to receive subcutaneous administration of placebo or erenumab 28 mg, 70 mg or 140 mg once every four weeks for six months. The primary endpoint was the change from baseline in mean MMD over months 4, 5, and 6 of the DBTP.5
About the 20170609 Study
The 20170609 study is a Phase III, randomized, placebo-controlled study comprised of a six-month (24 weeks) DBTP that evaluated the safety and efficacy of erenumab for migraine prevention in adult Japanese patients with episodic or chronic migraine. There were 261 participants randomized with a 1:1 allocation to receive subcutaneous administration of placebo or erenumab 70 mg once every four weeks. The primary endpoint was the change from baseline in mean MMD over months 4, 5, and 6 of the DBTP. Secondary endpoints were the proportion of participants with at least a 50% reduction in MMD and the change from baseline in mean monthly acute migraine-specific medication treatment days over months 4, 5, and 6 of the DBTP.6
People with frequent migraine attacks may lose more than half their life to migraine.9,10 One attack could last longer than three days.9 They 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.1,11 The 2019 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.12 Migraine is associated with personal and societal burdens of pain, disability and financial cost, and it remains under-recognized and under-treated.7,13
Aimovig® 70 mg solution for subcutaneous injection in pen
Erenumab (genetical recombination),
Suppression of onset of migraine attacks
Warnings and precautions related to indication:
• When considering the use of this drug, a thorough medical examination should be conducted to confirm that the patient is experiencing migraine episodes with or without aura more than once a month, or that the patient has chronic migraine.
• This product should only be administered to patients who are experiencing difficulties in their daily lives despite non-drug therapy, appropriate acute treatment for migraine attacks, with reference to the latest guidelines etc.
The usual adult dosage of erenumab (genetical recombination) is 70 mg subcutaneously once every 4 weeks.
About Aimovig in the
Aimovig (erenumab-aooe) is the first FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.3,14 Aimovig has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention.15,16 Aimovig is self-administered once monthly via the easy-to-use SureClick® autoinjector, without a required loading dose.14,17 More than 3,000 patients participated in registrational trials of Aimovig across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.15,16,18 - 20
Aimovig is also being evaluated through CATALYST, a comprehensive evidence generation program initiated by
IMPORTANT SAFETY INFORMATION REGARDING AIMOVIG
Aimovig® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.
Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.
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.
Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.
Monitor patients treated with Aimovig® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.
Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of Aimovig® in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. Aimovig® was discontinued in many of the reported cases.
Monitor patients treated with Aimovig® for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of Aimovig® is warranted if evaluation fails to establish an alternative etiology.
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.
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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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
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
Information on pharmaceutical products (including those under development) discussed in this news release is not intended to promote and advertise the products or offer medical advice.
- Russo AF. Annu Rev Pharmacol Toxicol. 2015;55:533-552.
- Sakai F, Igarashi H. Prevalence of Migraine in
Japan: A Nationwide Survey. Cephalalgia. 1997;17(1):15-22.
- Olesen J, Diener HS, Husstedt I, et al. Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Engl J Med. 2004;350(11):1104-1110.
- Novartis 2020 Annual Report,
January 26, 2021. Amgen( December 2015– November 2020). A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention. Identifier NCT02630459. https://clinicaltrials.gov/ct2/show/NCT02630459
- Takeshima, T.,
Sakai, F., Hirata, K, et al. Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study. Headache. June 2021.
- Lipton R, Bigal M, Diamond M, et al. Migraine prevalence, disease burden and the need for preventive therapy. Neurology. 2007; 68(5):343-349.
The Japanese Headache Society. Clinical Practice Guideline for Chronic Headache. 2013; https://www.jhsnet.net/english/guideline2013.pdf. Headache Classification Committeeof the International Headache Society(IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
- Lipton R, Stewart WF, Diamond S, et al. Prevalence and burden of migraine in
the United States: data from the American Migraine Study II. Headache. 2001;41(7):1-211.
- Rutberg S, Ohrling K. Migraine – more than a headache: Women's experiences of living with migraine. Disabil Rehabil. 2012;34(4):329-336.
- Steiner, T.J., Stovner, L.J., Jensen, R. et al. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain 2020.
- Diamond S, Bigal ME, Silberstein S, et al. Patterns of diagnosis and acute and preventive treatment for migraine in
the United States: results from the American Migraine Prevalence and Prevention study. Headache. 2007;47(3):355-363
- Aimovig® (erenumab-aooe) prescribing information,
Amgen, April 2020.
- Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382-390. doi:10.1016/S1474-4422(16)00019-3.
- Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425-434. doi:10.1016/S1474-4422(17)30083-2.
- Mead J, Dammerman R, Rasmuseen S, et al. Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine. Patient Preference and Adherence.
- Ashina M, Goadsby P, Reuter U, et al. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial.
European Journal of Neurology. January 2021.
- Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Sustained Efficacy and Safety of Erenumab in Episodic Migraine Patients Failing 2–4 Prior Preventive Treatments: 2-year Interim Results of the LIBERTY Open-Label Extension Study. Presented at the 18th Migraine Trust Virtual Symposium;
October 3-9, 2020; London, U.K.
- Wang S-J,
Roxas Jr, A, Saravia B, et al. Efficacy and Safety of Erenumab in Patients with Episodic Migraine from the EMPOWER Study. Presented at the 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
- Data on File.
Amgen, May 2021
View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-announces-approval-of-aimovig-erenumab-in-japan-for-the-suppression-of-onset-of-migraine-attacks-in-adults-301318079.html