NEJM publishes Novartis pivotal data showing treatment with erenumab (AMG 334) cuts migraine days by half
Nov 30, 2017
Data from the Phase III STRIVE study reported erenumab cut in half the number of days with migraine symptoms for 50 percent of patients with episodic migraine1
Across the UK, an estimated 8.5 million people live with migraine and research suggests the condition is likely to impact the lives of almost 200,000 people every day2
Erenumab is the first and only fully human monoclonal antibody specifically designed to block the CGRP receptor, which plays a critical role in migraine activation
Frimley, UK [30 November 2017] – Novartis today announced that the New England Journal of Medicine (NEJM) has published positive results from the pivotal Phase III STRIVE study, which showed 50 percent of people using erenumab 140 mg for six months instead of placebo saw the amount of migraines experienced over a month reduced by at least half.1
Migraine is more prevalent than diabetes, epilepsy and asthma combined3 and almost 200,000 people across the UK are impacted by migraine every day.2 There is an urgent need for new treatment options and erenumab is the first and only fully human monoclonal antibody of its kind designed to specifically prevent migraine. It works by blocking the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation.
“STRIVE is the first fully reported Phase III study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine,” said Peter Goadsby, M.D., Ph.D., FAHS, Director, NIHR-Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King’s College Hospital, London. “The results of STRIVE represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy. STRIVE, as with the monoclonal antibody developments generally, represents an incredibly important step forward for migraine understanding and migraine treatment.”
These data show erenumab can significantly reduce the number of monthly migraine days experienced by patients, with a 3.7-day and 3.2-day reduction with erenumab 140 mg and 70 mg, respectively, from a baseline of 8.3-days (1.8-day reduction with placebo). Additionally, 50 percent of patients treated with erenumab 140 mg had the number of days with migraine symptoms cut by at least half (this figure was 43.3% following treatment with erenumab 70 mg, and 26.6% with placebo). Results from the Migraine Physical Function Impact Diary (MPFID) show patients treated with erenumab also reported improved physical health and ability to participate in daily activities over the six month trial period. Furthermore, erenumab has been shown to be effective and tolerable over the long term with a safety profile comparable to placebo.1
“Migraine is too often trivialised as just a headache when, in reality, it can be a debilitating, chronic condition that can destroy lives” said Simon Evans, Chief Executive, Migraine Action. “The effects can last for hours – even days in many cases. An option that can prevent migraine and that is well tolerated is therefore sorely needed and we hope that this marks the start of real change in how this condition is treated and perceived.”
"Migraine is a highly debilitating neurological condition that affects millions of people across the UK; more must be done urgently in order to help reduce the huge personal, societal and economic burden associated with migraine”, said Dimitrios Georgiopoulos Chief Scientific Officer, Novartis UK. “Erenumab is the most significant breakthrough in this field in 20 years and it is now imperative we continue to work with all parties to make this well-tolerated and effective treatment option for migraine available to those who can benefit from it.”
Erenumab is the first investigational therapy targeting the CGRP pathway to have received FDA and EMA regulatory filing acceptance to date. The STRIVE study is one of the pivotal trials included in the US and EU regulatory applications under review for erenumab.
About STRIVE STRIVE (NCT02456740) is a global Phase III, multicentre, randomised 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 randomised 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. 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 4, 5 and 6).4
Secondary study endpoints assessed in the same treatment phase included the proportion of patients with a reduction of at least 50 percent from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days. The impact of migraine on physical function and the impact on everyday activities were each assessed as secondary endpoints by the novel Migraine Physical Function Impact Diary (MPFID).
Erenumab delivered clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints including those measured by the novel, validated Migraine Physical Function Impact Diary (MPFID)5. Treatment with erenumab was well tolerated, with a safety profile comparable to placebo1.
About erenumab (AMG 334) Erenumab (AMG 334) is the only treatment specifically designed to prevent migraine by blocking the CGRP receptor, which plays an important role in migraine activation. Erenumab has been studied in several large global, randomised, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 2,600 patients have participated in our clinical trial programme across the four placebo-controlled Phase II and Phase III clinical studies and their open-label extensions.
About Migraine Migraine is a distinct neurological disease.5 It 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 odours.6 Migraine is associated with personal pain, disability and reduced quality of life, and financial cost to society.7 It 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.8 It remains under-recognised and under-treated.7,9 Existing preventive therapies have been repurposed from other indications6 and are often associated with poor tolerability and lack of efficacy, with high discontinuation rates among patients.10
About Amgen and Novartis Neuroscience Collaboration In August 2015, Amgen entered into a global collaboration with Novartis to jointly develop and commercialise 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 (AMG 334) (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-commercialisation 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 commercialisation 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 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 121,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
In the UK, Novartis develops, manufactures and markets innovative medicines, devices and diagnostic tests which help improve patient outcomes. Based on four sites across the north and south of England, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis by manufacturing the active pharmaceutical ingredients used worldwide in many medicines. In 2016 Novartis in the UK invested almost £40million in R&D and is the largest commercial sponsor of clinical trials. For more information, please visit www.novartis.co.uk.
World Health Organization. Estimates for 2000-2012. Disease Burden. 2012.
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.
Hepp Z et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35(6):478-88.