Novartis (Frimley, UK) have announced that they have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the use of Aimovig® (erenumab) for the prevention of migraine in adult patients who experience more than 4 migraine days per month.
If Aimovig is approved, then it will be the first and only preventive treatment designed specifically to block the calcitonin gene-related peptide (CGRP) receptor which is thought to be responsible for transmitting pain signals associated with migraine.
Discover more on the approval stages of Aimovig in our news coverages below:
- June 2017: Monoclonal antibody could be an effective treatment for chronic migraine
- December 2017: Migraine attacks halved by antibody therapies
- February 2018: Latest erenumab trial signals hope for refractory migraine sufferers
- May 2018: Novel therapy for ‘difficult-to-treat’ migraines revealed
- May 2018: Aimovig® halves migraine days in late-stage study, heading towards possible May approval
- May 2018: Aimovig® gains US FDA approval for the preventive treatment of migraine
- June 2018: Aimovig® receives positive CHMP opinion for the prevention of migraine
Currently, there are approximately 10 million adults in the UK who suffer from migraines and a recent study has implicated that over a third of patients experience 4 or more migraine days a month (n = 8281). Many patients stop using treatments currently available to them due to limited efficacy rates and poor tolerability.
In an extensive clinical trial program involving 2600 migraine patients, researchers are evaluating the safety, efficacy and tolerability of Aimovig. Trials including both episodic and chronic migraine populations have revealed significant reductions in mean monthly migraine days experienced, with some patients achieving a 50% or greater reduction. In addition to this, Aimovig has also been reported to improve physical health and ability to participate in daily activities over a 6-month period.
“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, targeting option for those worst affected,” commented 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.”
Fayyaz Ahmed, a Consultant Neurologist at Hull and East Yorkshire Hospitals NHS Trust (Hull, UK), commented: “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.”
“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,” Ahmed concluded.
Aimovig was approved by the US FDA for the prevention of migraine in adults in May 2018. The EMA is now considering this CHMP opinion as it makes its final decision on the marketing authorization for Aimovig, which is expected within 3 months. Additional regulatory filings are underway with other health authorities worldwide.