Novartis receives European licence for Aimovig®▼(erenumab), the first treatment designed specifically for the prevention of migraine
Jul 31, 2018
Erenumab is the first and only licensed treatment designed to block the calcitonin gene-related peptide (CGRP) receptor, thought to beinvolved in migraine activation
Erenumab can be self-administered at home, once every four weeks via the SureClick® auto-injector pen, with no additional therapeutic monitoring required
Frimley, UK, July 31, 2018 – Novartis today announced that the European Medicines Agency (EMA) has granted a licence for the use of Aimovig® (erenumab) for the prevention of migraine in adults who experience at least four migraine days per month.
Erenumab is the first and only licensed preventative treatment designed specifically for migraine that blocks the calcitonin gene-related peptide (CGRP) receptor, thought to be involved in the transmission of the pain signals associated with migraine1.
Migraine is a complex and debilitating neurological condition that affects each individual differently. Latest information shows that over 610,000 people in the UK are estimated to experience chronic migraine (15 or more headache days per month of which eight involve migraine symptoms), with the 2010 Equality Act classing migraine as a disability should the condition have a long term, substantial impact on day to day or work-related activities. Latest research shows that around £9.7 billion a year is lost in the UK alone due to migraine through direct (treating patients) and indirect (lost productivity) costs, yet migraine remains the least publicly funded of all neurological illnesses relative to its economic impact,.
“Through collaboration with various healthcare professionals involved in migraine management, we’re proud to be delivering erenumab to those who need it most,” said Haseeb Ahmad, Country President of Novartis UK and Managing Director (UK & Ireland) of Novartis Pharmaceuticals. “Erenumab is the first and only licensed treatment specifically designed to prevent migraine, demonstrating our commitment to developing innovative therapies for people living with some of the most debilitating conditions.”
“Erenumab has been shown to reduce the average number of monthly migraine days in both episodic and chronic migraine patients, including those who have tried existing treatment options,” said Professor Zameel Cader, Consultant Neurologist at the Oxford University Hospitals NHS Foundation Trust and the Oxford Headache Centre. “Today’s news represents a new approach for the clinical community in our ability to treat those that suffer most with migraine.”
Initial decisions on erenumab for the prevention of migraine from the National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC) are expected in 2019. Novartis is working closely with all stakeholders to ensure eligible patients can start benefitting from this treatment as quickly as possible. A bespoke patient support programme and range of resources are also being developed in order to provide as much support as possible to patients and healthcare professionals.
About Aimovig (erenumab)
Erenumab is the only licensed treatment specifically designed for the prevention of migraine by blocking the CGRP receptor, thought to be involved in the transmission of the pain signals associated with migraine1. 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 2,500 adult migraine patients have participated in our clinical trial programme across the four placebo-controlled Phase II and Phase III clinical studies of between 12 weeks and six months in duration and their open-label extensions,,,. The safety data for erenumab to date are consistent, demonstrating a similar adverse event rate to placebo in clinical trials in patients with both episodic and chronic migraine6-9. The most common adverse events observed were injection site reactions, constipation, muscle spasms and pruritus. Erenumab can be self-administered at home, or by another trained individual, once every four weeks via the SureClick® auto-injector pen, with no additional therapeutic monitoring required.
Migraine is a common and disabling neurological condition that causes a wide variety of painful and debilitating symptoms, including but not limited to severe headache. Latest research shows that around 10 million UK adults (aged 15-69) experience migraine4, with estimates showing there are over 190,000 migraine attacks every day5. Migraine is more prevalent than diabetes, epilepsy and asthma combined5 and classified as the highest cause of years lived with disability amongst those aged 15-494. 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 productivity4.
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 and devices which help improve patient outcomes. Based on three 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.
 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