Amgen and Novartis’ closely watched experimental migraine therapy Aimovig has impressed again in late stage trials, this time hitting targets in patients for which other preventative treatments failed to work or weren’t tolerated.
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 “uniquely difficult-to-treat population often excluded from migraine prevention trials,” the firm noted.
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).
Aimovig is a fully human monoclonal antibody specifically designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, which is thought to play a critical role in mediating the incapacitating pain of migraine.
Its mode of action differs from other similar migraine therapies in development, which target CGRP itself as opposed to the receptor pathway.
“The LIBERTY study distinctively demonstrates the ability of an anti-CGRP receptor antibody to significantly reduce migraine frequency and its associated burden in patients who could not find the relief they need from currently available preventive treatment options,” said professor Uwe Reuter, managing medical director at Charité Universitätsmedizin in Berlin.
“These compelling data offer new hope of fewer migraine days to those people with migraine who may have cycled through current standard of care unsuccessfully for years due to lack of efficacy and tolerability.”
Aimovig is currently under review on both sides of the Atlantic, with a US decision expected next month.
If approved, 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 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.