Novartis has announced that the European Commission (EC) approved Aimovig ® (erenumab) for the prevention of migraine in adults experiencing four or more 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 US and Australia. It works by blocking a receptor called the calcitonin gene-related peptide receptor (CGRP-R) which plays a critical role in mediating the incapacitating pain of migraine.
“A treatment specifically designed for migraine prevention is a much-welcomed innovation and could transform lives of patients”
In the extensive clinical program of 2,600 patients, those on Aimovig experienced significant reductions in their number of migraine days per month, with a safety and tolerability profile similar to placebo. Aimovig can be self-administered or administered by another trained person every four weeks with the SureClick® autoinjector pen, an established device commonly used for a range of different conditions.
Aimovig showed efficacy even in a difficult-to-treat population. It is the only CGRP-R pathway therapy specifically studied in patients who had failed on two to four previous treatments commonly used for migraine prevention. Furthermore, in an interim analysis from a five year open label extension (OLE) in episodic migraine, it was demonstrated that more than one in four (26%), patients taking Aimovig 70mg, who were still enrolled and assessed for migraine over month fifteen, were completely migraine free.
Patrick Little, President of the European Migraine and Headache Alliance said, “Migraine matters. It is a painful, highly disruptive neurological disease that affects all aspects of life, from going to work to spending time with family and friends. A treatment specifically designed for migraine prevention is a much-welcomed innovation and could transform lives of patients for whom current therapies do not work or are not well tolerated.”
Peter Goadsby, M.D., Ph.D., FRCP, Director, NIHR-Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King’s College London said, “Erenumab heralds a new era in clinical practice, bringing both a targeted mechanism for prevention and a deep understanding of migraine, which we have never had before. We will see sustained relief from migraine for many of those who suffer with this debilitating disease.”
Paul Hudson, CEO Novartis Pharmaceuticals said, “In clinical trials, Aimovig has consistently shown to be effective in preventing migraine and bringing relief from the grip of this disease. We are committed to ensuring Aimovig’s availability for those who could benefit from it.”
Erenumab is not currently expected to be made available via the NHS until 2019, but NHS patients can talk today to their specialist about getting a prescription and importing the drug without any delay through TheSocialMedwork. The medicine, erenumab, (trade name Aimovig) is available to order now with a doctor’s prescription via TheSocialMedwork and will be delivered in around 12 days.
TheSocialMedwork founder Sjaak Vink commented,
“In response to the news that the migraine prevention drug, erenumab, has been given approval by the European Medicines Agency (EMA) yesterday, we’re happy to inform UK migraine sufferers that the drug is available to access today through our medicines intermediary service TheSocialMedwork”
“People who suffer from migraines have endured shortfalls of existing treatment options for too long. This new medicine is, according to the results from studies published by EMA, a breakthrough, which is why it should be accessible to everyone. Delays between global approvals and availability can be months to years. No one should continue to suffer because of bureaucracy.”