Novartis (NVS) Announces AMG 334 Phase 3 Met Primary Endpoint as Migraine Treatment

November 16, 2016 4:35 PM EST

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Novartis (NYSE: NVS) announced positive topline results from the global Phase III STRIVE study, evaluating the efficacy and safety of the fully human monoclonal antibody AMG 334 (erenumab) in episodic migraine prevention. Once-monthly subcutaneous AMG 334 was evaluated at 70mg and 140mg doses, with both doses meeting the study's primary endpoint, demonstrating a statistically significant reduction from baseline in mean monthly migraine days at six months versus placebo.[1] AMG 334 is specifically designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor that is believed to have a critical role in mediating the incapacitating pain of migraine.[2]

"Migraine is one of the world's most disabling diseases, and it remains under-recognized and under-treated. There is a significant need for effective, preventative treatments," said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. "We have now seen positive results with AMG 334 from two Phase III studies in episodic migraine and the Phase II study in chronic migraine, involving almost 2,200 people with migraine. We're really excited that these new six-month data provide further evidence of the potential benefit AMG 334 could provide to people living with the debilitating symptoms of this disease."

Patients enrolled in STRIVE were randomized to receive either placebo, or one of two AMG 334 doses, 70mg or 140mg, subcutaneously, once monthly, for six months.[1] Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline.[1] Over the last three months of the double-blind treatment phase, patients in the 70mg and 140mg AMG 334 treatment arms experienced a statistically significant 3.2-day and 3.7-day reduction from baseline in mean monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.[1]

The safety profile of AMG 334 was comparable to placebo across both treatment arms over the six-month double-blind evaluation.[1] The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and sinusitis.[1]

Further analysis of the STRIVE data is ongoing. Positive results from ARISE, the first Phase III study of AMG 334 in episodic migraine prevention, and results from a Phase II study of AMG 334 in chronic migraine prevention, were announced earlier this year.[3,4] These data will help support discussions with regulatory agencies, with filing anticipated in 2017.
More complex than just a headache, migraine has been declared by the World Health Organization to be one of the top 10 causes of years lived with disability for men and women.[5] It has a profound and limiting impact on an individual's ability to carry out everyday tasks and there is a real need for more effective preventative treatments to help reduce the number of monthly migraine days individuals experience.[6] People with episodic migraine experience up to 14 migraine days each month.[7]

AMG 334 is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen has commercialization rights in the U.S., Canada and Japan, and Novartis has commercialization rights in Europe and the rest of the world.

About the STRIVE study (NCT02456740)
STRIVE (NCT02456740) is a global Phase III, multicenter, randomized 24-week, double-blind, placebo-controlled study evaluating the safety and efficacy of AMG 334 in episodic migraine prevention.[8] In the study, 955 patients were randomized to receive once-monthly subcutaneous placebo, or AMG 334 (70mg or 140mg) in a 1:1:1 ratio.[1,8] Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline.[1] The primary endpoint was change in mean monthly migraine days from baseline over the last three months of the double-blind treatment phase of the study (months four, five and six).[1,8]

Secondary study endpoints assessed in the last three months of a six-month double-blind treatment phase included the proportion of patients with a reduction of at least 50% from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in both mean impact on everyday activities domain and mean physical impairment domain scores on the Migraine Physical Function Impact Diary (MPFID).[8]

References

1Novartis data on file.
2Bigal ME et al. Calcitonin Gene-Related Peptide (CGRP) and Migraine Current Understanding and State of Development. Headache. 2013;53(8):1230-1244.
3Novartis announces Phase III study shows AMG 334 significantly reduces monthly migraine data in people with episodic migraine. https://www.novartis.com/news/media-releases/novartis-announces-phase-iii-study-shows-amg-334-significantly-reduces-monthly. Accessed October 2016.
4Novartis 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 October 2016.
5World Health Organization. Estimates for 2000-2012. Disease Burden. 2012.
6Buse 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.
7Katsarava Z et al. Chronic migraine: Classification and comparisons. Cephalalgia. 2011;31:520-529.
8ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention (STRIVE). https://clinicaltrials.gov/ct2/show/NCT02456740 (link is external) (link is external). Accessed October 2016.
9National 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 October 2016
10World Health Organization. Headache disorders. http://www.who.int/mediacentre/factsheets/fs277/en/ (link is external) (link is external). Accessed October 2016.
11Diamond 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.
12National 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 October 2016.
13Headache 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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