Phase III STRIVE study data for erenumab (AMG334) in migraine prevention published in The New England Journal of Medicine(1)

• Patients with episodic migraine taking investigational treatment erenumab over six months reported reduced migraine days and acute medication use¹
  
  
• Fifty per cent of patients taking erenumab 140mg had their migraine days cut by at least half¹
  
  
• Patients on erenumab reported reduced physical impairment and improved ability to participate in daily activities based on a validated patient-reported outcome tool¹

DORVAL, QC, Nov. 30, 2017 /CNW/ - Novartis has announced that The New England Journal of Medicine (NEJM) has published results from the six-month Phase III STRIVE study evaluating the investigational treatment erenumab in the prevention of episodic migraine (defined in the study as 4 to 14 migraine days per month)¹. Erenumab is specifically designed to block the calcitonin gene-related peptide (CGRP) receptor, which is known to play an important role in migraine activation¹. Erenumab is an investigational treatment that is not currently approved for use in Canada or elsewhere. 

"We are pleased to have been able to evaluate this new approach to migraine prevention.  Migraine can be a crippling condition for the more than eight per cent of Canadians who suffer from it²," said Dawn Bell, Chief Scientific Officer, Novartis Pharmaceuticals Canada Inc. "The results from this study are important clinical evidence for this investigational therapy and we are pleased to be conducting research in this area."

The STRIVE study enrolled 955 patients, who were randomized to receive either placebo or subcutaneous (injection administered under the skin) erenumab 70mg or 140mg once a month, for six months. Five centers in Canada participated in the study³. Overall, erenumab treatment resulted in statistically significant differences from placebo for all primary and secondary endpoints1 including number of migraine days, acute medication use, as well as reduced physical impairment and greater ability to participate in daily activities, as measured by the novel, validated Migraine Physical Function Impact Diary (MPFID)⁴.

"The STRIVE study is the first fully completed phase III study of a preventive migraine medication acting on the CGRP pathway. These results represent a step forward for migraine understanding and preventive migraine treatment development," said Dr. Suzanne Christie, neurologist and Director at The Ottawa Headache Centre in Ottawa, Ontario and one of the STRIVE study investigators. "Migraine is more than a headache. For migraine sufferers it is a very serious condition that can substantially impact all aspects of person's daily life. As a treating physician, migraine prevention is a high priority."

About STRIVE
STRIVE (NCT02456740) is a global Phase III, multicentre, randomized 24-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in episodic migraine (4 to 14 migraine days a month) prevention. In the study, 955 patients were randomized to receive once-monthly subcutaneous placebo, or erenumab (70mg or 140mg) in a 1:1:1 ratio. Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline.

In STRIVE, patients taking erenumab at the higher 140mg dose experienced a significant 3.7-day reduction in monthly migraine days from the baseline of 8.3 days (3.2-day reduction with 70mg, 1.8-day reduction with placebo, both p<0.001). Fifty percent of patients taking erenumab 140mg had their migraine days cut by at least half (43.3% with 70mg; 26.6% with placebo, both p<0.001; odds ratios of 2.8 and 2.1 respectively for 140mg and 70mg). STRIVE endpoints were assessed from baseline to the average of the last three months (months 4, 5, 6)¹.

In STRIVE, more than 90 per cent of patients taking erenumab completed the study. Adverse reactions leading to discontinuation of treatment occurred in 2.2 per cent of erenumab-treated patients and in 2.5 per cent of patients receiving placebo¹. STRIVE contributes to the body of evidence on erenumab, including four placebo-controlled Phase II and Phase III clinical studies involving more than 2,600 patients, as well as an ongoing open-label extension up to five years in duration.

About Migraine
Migraine is a chronic biological disorder that causes recurrent attacks of head pain that is often associated with nausea and vomiting and can involve sensitivity to light and sound⁵.

Migraine causes significant disability, seven million workdays are reportedly lost to it annually, which is likely under-reported. Most sufferers develop their first migraine headache in adolescence or early adulthood⁶. The highest prevalence rates in Canada are among people in their 30s and 40s and women are more than twice as likely as men to report having migraine. People with migraine are much more likely to suffer from depression. It is a disease that impacts many areas of daily living, including education, work, sleep, and driving².

About Amgen and Novartis Neuroscience Collaboration
In August 2015, Amgen entered into a global collaboration with Novartis to jointly develop and commercialize pioneering treatments in the field of migraine and Alzheimer's disease (AD). The collaboration focuses on investigational Amgen drugs in the migraine field, including erenumab (Biologics License Application submitted to U.S. FDA in May 2017) and AMG 301 (currently in Phase 1 development). In April 2017, the collaboration was expanded to include co-commercialization of erenumab in the U.S. For the migraine program, Amgen retains exclusive rights in Japan, and Novartis has exclusive rights in Europe, Canada and rest of world. Also, the companies are collaborating in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD. The oral therapy CNP520 (currently in Phase 3 for AD) is the lead molecule and further compounds from both companies' pre-clinical BACE inhibitor programs may be considered as follow-on molecules.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2016, the company invested $48.8 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 750 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.   

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, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 119,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

References
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¹ Goadsby PJ et al., Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132.

² Ramage-Morin PL, Gilmour H, (Statistics Canada) Prevalence of migraine in the Canadian household population, Health Reports. 2014 Jun;25(6):10-16, accessed Nov. 14, 2017, at: https://www.statcan.gc.ca/pub/82-003-x/2014006/article/14033-eng.htm

³ ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention (STRIVE). Study Locations, accessed Nov. 14, 2017, at: https://clinicaltrials.gov/ct2/show/study/NCT02456740?show_locs=Y#locn

⁴ 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. Accessed Nov. 14, 2017, at: https://www.ncbi.nlm.nih.gov/pubmed/28857154 

⁵ Canadian Headache Society, What is Migraine? Accessed Nov. 14, 2017, at: http://www.migrainecanada.org/index.php/diagnosis/220-what-is-migraine

⁶ The Ontario Migraine Clinic, What is Migraine? Accessed Nov. 14, 2017, at: http://www.migraineclinic.ca/migraines.html

SOURCE Novartis Pharmaceuticals Canada Inc.

For further information: Novartis Media Relations, Patricia Tiramani, Novartis Pharmaceuticals Communications , [phone], E-mail: [email protected]; Spectrum Advisors, [phone], [email protected]