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Novartis announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention.
The study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with AMG 334 compared with placebo at 12 weeks.[1] AMG 334 is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor that is believed to have a critical role in mediating the incapacitating pain of migraine.[2]
“People who suffer from episodic migraine experience substantial pain, disability and physical impairment, which can significantly disrupt their ability to participate in everyday activities,” said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “The positive results from ARISE are especially encouraging because there are currently no treatment options specifically designed for the prevention of migraine. These findings, in combination with the recent positive data in chronic migraine prevention, add to the growing body of evidence that shows AMG 334 has the potential to help individuals worldwide suffering from episodic and chronic migraine.”
A total of 577 patients enrolled in ARISE were randomized to receive either placebo or AMG 334 at 70mg subcutaneously, once monthly.[1],[3] Patients experienced between four and 14 migraine days each month, with an average of eight migraine days per month at baseline.[1],[3] Those receiving AMG 334 experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, as compared to a 1.8-day reduction in the placebo arm.[1]
The safety profile of AMG 334 was similar to placebo and consistent with previously-reported studies.[1] The most common adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis.[1]
Further analysis of the ARISE data is ongoing, and will be submitted to a future medical meeting and for publication. The STRIVE study, a second Phase III episodic migraine study evaluating both 70mg and 140mg doses of AMG 334 for 24 weeks, is expected to be completed by the end of this year. Positive results from a Phase II study of AMG 334 in chronic migraine prevention were also announced earlier this year.[4]
Migraine is more than just a headache; it is the most prevalent of all neurological disorders and affects more than 10% of the worldwide population.[5]-[8] Migraine has a profound and limiting impact on an individual’s abilities to carry out everyday tasks, and was declared by the World Health Organization to be one of the top 10 causes of years lived with disability for men and women.[9], [10] People with episodic migraine experience up to 14 migraine days each month.[11]
AMG 334 is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and the rest of the world.
About Migraine
Migraine involves recurrent attacks of moderate to severe head pain that is typically pulsating, often unilateral and associated with nausea, vomiting and sensitivity to light, sound and odors.[12] Migraine is associated with personal pain, disability and reduced quality of life, and financial cost to society.[13] It remains under-recognized and under-treated with more than 40% of people going undiagnosed.[13],[14] Worldwide, approximately 90% of people diagnosed with migraine have episodic migraine, which is characterized by one to 14 migraine days a month.[11],[15] The remaining 10% have chronic migraine, which is characterized by at least 15 headache days per month, of which eight or more days have migraine features, for more than three months.[15],[16]
About the Amgen and Novartis Neuroscience Collaboration
In August 2015, Novartis entered into a global collaboration with Amgen to jointly develop and commercialize pioneering neuroscience treatments in the field of Alzheimer’s Disease (AD) and migraine. The companies are partnering in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD. Novartis’ oral therapy CNP520 (currently in a Phase II study for AD) will be the lead molecule and further compounds from both companies’ pre-clinical BACE inhibitor programs may be considered as novel follow-on molecules. The collaboration also focuses on innovative investigational Amgen drugs in the migraine field, including AMG 334 (currently in Phase III studies for episodic migraine and a Phase II study for chronic migraine) and AMG 301 (currently in a Phase I study). For the migraine program, Novartis will have global co-development rights and commercial rights outside the U.S., Canada, and Japan.
About Novartis in Neuroscience
Novartis has a strong ongoing commitment to neuroscience (NS) and to bringing innovative treatments to patients suffering from neurological conditions where there is a high unmet need. We currently offer patients and physicians a large drug portfolio encompassing Multiple Sclerosis (MS), Alzheimer’s disease, Parkinson’s disease, Epilepsy and Attention Deficit Hyperactivity Disorder, and have a promising pipeline in MS, Alzheimer’s disease, migraine and specialty neurology (e.g. neuropathic pain).
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
References
[1] Novartis data on file
[2] Bigal ME et al. Calcitonin Gene-Related Peptide (CGRP) and Migraine Current Understanding and State of Development. Headache. 2013;53(8):1230-1244.
[3] ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of AMG 334 Compared to Placebo in Migraine Prevention (ARISE). https://clinicaltrials.gov/ct2/show/NCT02483585?term=ARISE+amg+334&rank=1 (link is external) (link is external). Accessed September 2016.
[4] Novartis presents new positive data at EHMTIC showing AMG 334 significantly reduces monthly migraine days in chronic migraine. https://www.novartis.com/news/media-releases/novartis-presents-new-positive-data-ehmtic-showing-amg-334-significantly-reduces. Accessed September 2016.
[5] Edvinsson L. CGRP receptor antagonists and antibodies against CGRP and its receptor in migraine treatment. Br J Clin Pharmacol. 2015;80(2):193-9.
[6] Hirtz D et al. How common are the “common” neurologic disorders? Neurology. 2007; 68(5):326-37.
[7] Vos T et al. Global Burden of Disease Study. Lancet. 2015;386(9995):743-800.
[8] Stovner L et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193-210.
[9] Buse DC et al. Assessing and Managing All Aspects of Migraine: Migraine Attacks, Migraine-Related Functional Impairment, Common Comorbidities, and Quality of Life. Mayo Clin Proc. 2009;84(5):422-435.
[10] World Health Organization. Estimates for 2000-2012. Disease Burden. 2012.
[11] Katsarava Z et al. Chronic migraine: Classification and comparisons. Cephalalgia. 2011;31:520-529.
[12] National Institute for Neurological Disorders and Stroke. Headache: Hope Through Research. http://www.ninds.nih.gov/disorders/headache/detail_headache.htm (link is external) (link is external). Accessed September 2016.
[13] World Health Organization. Headache disorders. http://www.who.int/mediacentre/factsheets/fs277/en/ (link is external) (link is external). Accessed September 2016.
[14] Diamond 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):355-63.
[15] National Migraine Centre. What is migraine? http://www.nationalmigrainecentre.org.uk/migraine-and-headaches/migraine-and-headache-factsheets/what-is-migraine/ (link is external) (link is external). Accessed September 2016.
[16] Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33:629-808.
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