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MAA for Migraine Treatment Erenumab Accepted for Review
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The anti-CGRP monoclonal antibody showed long-term efficacy versus placebo in migraine pain impact.
The European Medicines Agency (EMA) has accepted a Marketing Authorization Application (MAA) for the first anti-calcitonin gene-related peptide (CGRP) treatment for migraine prevention.
AMG 334 (erenumab), a monoclonal antibody produced by pharmaceutical company Novartis, was approved by the EMA June 21st, after having submitted 4 positive Phase II and III clinical trial results versus placebo, which included over 2,600 migraine patients.
In trials, erenumab demonstrated statistically significant long-term efficacy versus placebo in the reduction of patient monthly migraine days. It also significantly improved the impact of migraines on patient disability and quality of life versus placebo.
An extension trial to evaluate erenumab’s long-term safety in migraine patients for up to 5 years is currently ongoing.
Erenumab is the only monoclonal antibody that binds selectively to the CGRP receptor — which has been believed by researchers for years to play a crucial role in mediating migraine pain.
Vas Narasimhan, global head drug development and chief medical officer for Novartis, expressed excitement for the company’s most recent success in a history of clinical neurology practice.
"We look forward to continuing this legacy by working with the European health authorities on our goal to make our fully human monoclonal antibody, erenumab, the first new therapy available to migraine patients in over a decade,” Narasimhan.
Novartis and biotechnology company Amgen — which also owns the drugs’ exclusive commercialization rights in Japan — will co-commercialize erenumab in the US.
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