Novartis receives positive CHMP opinion for Aimovig® (erenumab), the first preventative treatment designed specifically for migraine
Jun 01, 2018
Recommendation based on extensive clinical trial programme data involving 2,600 migraine patients evaluating the safety, efficacy and tolerability of Aimovig1,2,3,4
An estimated 10 million UK adults live with migraine and less than 50% of migraine patients are satisfied with their current treatment5,6
If approved, Aimovig will be the first and only preventative treatment designed specifically for migraine that blocks the calcitonin gene-related peptide (CGRP) receptor
Frimley, UK, June 01, 2018 – Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Aimovig® (erenumab) for the prevention of migraine in adult patients who experience more than four migraine days per month. If approved, Aimovig will be the first and only preventative treatment designed specifically for migraine that blocks the calcitonin gene-related peptide (CGRP) receptor thought to be responsible for transmitting the pain signals associated with migraine7.
There are currently around 10 million adult migraine sufferers in the UK and a recent study demonstrated that just over a third of migraine patients experienced four or more migraine days a month (n=8281)5,8 . Migraine is an unpredictable and complex neurological condition that causes a wide variety of painful and debilitating symptoms, including but not limited to severe headache9. Despite the prevalence and impact of migraine, many patients stop using the treatments currently available to them due to limited efficacy rates and poor tolerability10.
There is an extensive clinical trial programme involving 2,600 migraine patients evaluating the safety, efficacy and tolerability of Aimovig. Trials in both episodic and chronic migraine populations have demonstrated significant reductions in mean monthly migraine days, with some patients achieving a 50% or greater reduction1-4. Additionally, results from the Migraine Physical Function Impact Diary (MPFID) used in the STRIVE study show patients treated with Aimovig reported improved physical health and ability to participate in daily activities over the six month trial period2.
“There are millions of people in the UK whose lives can be completely disrupted by migraine, from their ability to work to spending time with their families. People with migraine have had to put up with little progress in their treatment in decades but today’s decision marks a hugely significant step towards delivering a new, targeted option for those worst affected,” said Haseeb Ahmad, Country President of Novartis UK and Managing Director (UK & Ireland) of Novartis Pharmaceuticals. “Aimovig has the potential to change the way many people severely affected with migraine manage their condition for the first time in a generation, empowering them by reducing the impact of migraine symptoms on their lives.”
“Migraine patients are experts in their own disease but currently don’t have the tools they need to be able to self-manage their condition effectively. Many of the patients we see, particularly those with more chronic migraine, have tried several treatment options with limited to no success,” said Dr Fayyaz Ahmed, Consultant Neurologist at Hull and East Yorkshire Hospitals NHS Trust. “This is a really exciting time in headache research. Aimovig shows the potential to offer a significant reduction in headache days through an easy-to-use format, marking an exciting opportunity for the neurology community to begin to tackle migraine in a totally new way.”
The European Medicines Agency (EMA) will now consider this guidance from the CHMP as it makes its final decision on the marketing authorisation for Aimovig, expected within three months. Aimovig was approved by the U.S. Food and Drug Administration (FDA) for the prevention of migraine in adults in May 2018 and additional regulatory filings are underway with other health authorities worldwide.
About Aimovig (erenumab) Aimovig is the only treatment specifically designed to prevent migraine by blocking the CGRP receptor, which plays an important role in migraine activation. Aimovig 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 extensions1-4. The most common adverse events observed were injection site reactions, constipation, muscle spasms and pruritus. Aimovig can be self-administered at home, once every four weeks via auto-injector and does not require routine monitoring.
About Migraine Migraine is a common and disabling neurological condition that causes a wide variety of painful and debilitating symptoms, one of which is a headache9. Latest research shows that around 10 million UK adults (aged 15-69) experience migraine5, with estimates showing there are over 190,000 migraine attacks every day6. Migraine is more prevalent than diabetes, epilepsy and asthma combined6 and classified as one of the highest cause of years lived with disability by the World Health Organisation . Despite this, migraine remains undiagnosed and undertreated in at least 50% of patients . An estimated £9.7 billion a year is lost in the UK alone due to migraine through direct and indirect costs: in treating patients and in lost productivity5.
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 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 124,000 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 2017 Novartis invested almost £30million in R&D and is a leading sponsor of clinical trials in the UK. For more information, please visit www.novartis.co.uk.
Novartis UK Media Relations Novartis UK Press Office Tel: 01276 698 691 E-Mail: [email protected]
Dodick DW et al. ARISE: A Phase 3 randomised trial of erenumab for episodic migraine. Cephalalgia. 2018 Jan 1:333102418759786
Goadsby P,et al. STRIVE Trial of erenumab for episodic migraine. NEJM Nov 2017
Reuter, U et al. Efficacy and safety of erenumab in episodic migraine patients with 2–4 prior preventive treatment failures: Results from the Phase 3b LIBERTY study. Emerging science abstract presented at AAN, 24 April 2018, Los Angeles
Tepper S,et al. Safety and efficacy of erenumab for preventative treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434
Blumenfeld et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011 Feb;31(3):301-15 https://www.ncbi.nlm.nih.gov/pubmed/20813784 . Accessed May 2018