Novartis (Frimley, UK) has announced that the EMA has granted license for the use of Aimovig® (erenumab) for the prevention of migraine in adults who experience at least four migraine days per month. Aimovig is the first and only treatment specifically designed for migraine prevention to be approved in the European Union, Switzerland, the USA and Australia.
The latest information on migraine reveals that over 610,000 individuals in the UK are estimated to experience chronic migraines (15 or more headache days per month, of which eight involve migraine symptoms), with the 2010 Equality Act classifying migraine as a disability should the condition have a long-term, substantial impact on day to day or work-related activities.
In addition to this, approximately £9.7 billion a year is lost in the UK 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.
Earlier this year in May, Novartis (Basel, Switzerland) and Amgen (CA, USA) announced that erenumab had gained US FDA approval.
The EMA submission of erenumab was supported by a clinical development program involving more than 2600 patients. Results from the STRIVE study, which was published last November, demonstrated that 50% of patients given the higher subcutaneous dose of the drug had their migraine days cut by at least half – representing nearly three-fold higher odds compared with placebo.
“Through collaboration with various healthcare professionals involved in migraine management, we’re proud to be delivering erenumab to those who need it most,” commented Haseeb Ahmad, Managing Director of Novartis Pharmaceuticals.
Zameel Cadar, a Consultant Neurologist at the Oxford University Hospitals NHS Foundation Trust (UK) explained: “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. Today’s news represents a new approach for the clinical community in our ability to treat those that suffer most with migraine.”
The EMA decision is applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein. Initial decisions on erenumab for the prevention of migraine from NICE and the Scottish Medicine Consortium are expected in 2019.
Novartis is working closely with all stakeholders to ensure eligible patients can start benefiting from this treatment as quickly as possible.
Read more about erenumab:
Source: Novartis. Novartis receives European license for Aimovig® (erenumab), the first treatment designed specifically for the prevention of migraine. Press release: www.novartis.com/news/media-releases/novartis-marks-new-era-migraine-patients-eu-approval-aimovigr-first-its-kind-treatment-specifically-designed-migraine-prevention; www.novartis.co.uk/news/uk-news-and-media-releases?type=All