Novartis has obtained approval from the European Commission (EC) for the use of Aimovig (erenumab) to prevent migraine in adults who experience four or more migraine days a month.
Aimovig is designed to block the calcitonin gene-related peptide receptor (CGRP-R), which is associated with mediation of the incapacitating migraine pain.
The drug is specifically developed for migraine prevention, and is said to be the first of this type of product to be approved in the European Union, Switzerland, the US and Australia.
It can be self-administered or given by a trained person every four weeks using the SureClick autoinjector pen that is commonly used for various conditions.
In a 2,600-subject clinical programme, those administered with Aimovig are reported to have achieved a significant decrease in the number of migraine days per month.
The safety and tolerability profile of the drug was found to be similar to that of the placebo.
Novartis Pharmaceuticals CEO Paul Hudson 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 proud to be the first to reimagine migraine prevention and we are committed to ensuring Aimovig’s availability for those who could benefit from it.”
Aimovig is said to have demonstrated efficacy in a difficult-to-treat population, including patients who failed on between two and four prior therapies that are commonly used for migraine prevention.
An interim analysis from a five-year open label extension (OLE) in episodic migraine further revealed that 26% of patients administered with 70mg of Aimovig were completely migraine free.
These patients are currently enrolled and evaluated for migraines at month 15.
Novartis has launched a tailored post-approval access programme to offer the drug in regions that allow for the use of unapproved or yet to be reimbursed treatments.
The company is additionally devising support programmes to provide personalised services, information and resources for eligible patients while they commence Aimovig treatment.