Novartis (Basel, Switzerland) and Amgen (CA, USA) have announced that the US FDA has approved Aimovig® (erenumab) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine.
“Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine. We look forward to working closely with Amgen in the US to bring this treatment to physicians and their patients, who could now gain days of their lives back each month,” commented Paul Hudson, CEO of Novartis.
At the end of last month, Amgen announced final data from its Phase IIIb LIBERTY clinical trial of Aimovig, with the positive results anticipated to lead to a blockbuster drug for migraine sufferers and a possible approval by the end of May.
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In Phase II and III studies in chronic and episodic migraine, Aimovig resulted in significant reductions in monthly migraine days and use of acute migraine medications compared to placebo. These effects on monthly migraine days have been shown to be sustained for up to 15 months in an ongoing open-label extension study in episodic migraine (4–14 headache days per month).
The efficacy, tolerability and safety of Aimovig has been assessed in more than 3000 patients, including the LIBERTY trial and an ongoing open-label extension of up to 5 years in duration. In clinical studies of Aimovig, the most common adverse reactions were injection site reactions and constipation.
Stewart Tepper, a professor of neurology at Dartmouth Medical School (NH, USA), stated: “Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success. Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy – with a discontinuation rate of 2% due to adverse events – and experienced sustained migraine prevention.”
“For years, the migraine community has been advocating for new treatment options that are specifically designed to treat migraine, a debilitating and often stigmatized disease,” explained Kevin Lenaburg, the Executive Director of the Coalition for Headache and Migraine Patients (PA, USA).
“Today we celebrate the tireless work of researchers to better understand the biology of migraine and their ability to bring a new therapeutic approach to the millions of Americans who are seeking fewer migraine days. On behalf of the community, we would also like to thank the thousands of clinical trial patients whose unwavering commitment made this progress possible.”
Aimovig is expected to be available to patients within 1 week.
Novartis is also anticipating the approval of Aimovig in the coming months, as the European Medicines Agency Marketing Authorization Application is currently under review.
Sources: www.amgen.com/media/news-releases/2018/05/fda-approves-aimovig-erenumabaooe-a-novel-treatment-developed-specifically-for-migraine-prevention/; www.novartis.com/news/media-releases/novartis-and-amgen-announce-fda-approval-aimovigtm-erenumab-novel-treatment-developed-specifically-migraine-prevention