Novartis data shows treatment with erenumab (AMG 334) cuts migraine days by half

Posted in Industry News,Online First on 4th Dec 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.

On 30th November, Novartis 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. 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.”
Simon Evans, Chief Executive, Migraine Action

“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 placebo.1

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.

www.novartis.co.uk

References

1 Goadsby et al. Trial of Erenumab for Episodic Migraine. NEJM Oct 2017

2 The Migraine Trust. Facts and Figures-Key Facts and Figures about Migraine. Available at: https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/. Accessed October 2017.

3 All-Party Parliamentary Group on Primary Headache Disorders. Headache Disorders – not respected, not resourced. Available at: http://www.migrainetrust.org/wp-content/uploads/2015/12/2010Mar-APPGPHD_REPORT_Headache_Disorders-NotRespNotReso.pdf. Accessed October 2017.

4 ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention (STRIVE). Available at: https://clinicaltrials.gov/ct2/show/NCT02456740. Accessed October 2017.

5 Migraine Research Foundation. Migraine Fact Sheet. 2015. Available at: http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed September 2017.

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