Amgen and Novartis’ Aimovig has become the first anti-CGRP therapy to win regulatory clearance in the US, winning approval for migraine prevention.
The monoclonal antibody offers patients a novel therapeutic approach as the first to block the calcitonin gene-related peptide receptor (CGRP-R), which is thought to play a critical role in migraine.
Its mode of action differs from other similar migraine therapies in development, which target CGRP itself as opposed to the receptor pathway.
The Phase IIIb LIBERTY trial assessed Aimovig (erenumab) in episodic migraine patients who had previously tried two to four therapies without success, thus representing a difficult-to-treat population often excluded from migraine prevention trials.
Results show that patients taking the drug had almost three-fold higher odds of having their migraine days cut by half or more compared to placebo, with more than twice as many patients taking Aimovig achieving this reduction (30.3 percent versus 13.7 percent, respectively).
"Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine. Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success," said Stewart Tepper, professor of Neurology at the Geisel School of Medicine at Dartmouth Medical School.
"Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy - with a discontinuation rate of two percent due to adverse events - and experienced sustained migraine prevention."
Novartis and Amgen plan to co-commercialise Aimovig in the US, while Amgen has exclusive commercialisation rights in Japan and Novartis in rest of world.
The drug is expected to be available in the US within a week, with a list price of $575 for once monthly 70mg or 140mg single-use prefilled SureClick autoinjectors, or $6,900 annually.
“The price of Aimovig reflects the value it brings to patients and society, including the financial impact on sufferers, caregivers and employers, while also factoring in critical issues such as patient affordability, and fair and timely access,” Novartis said.
The World Health Organisation considers migraine to be one of the top ten causes of disability for men and women, and yet, it remains an area of significant unmet medical need.
The drug has been under review in the EU since June last year, and Novartis says it expected approval in there “in the coming months”.