FDA approves blockbuster migraine treatment

FDA approves blockbuster migraine treatment

1200 800 Mea Holm, PhD

On May 17th, 2018, the US FDA approved Aimovig™ (erenumab) following successful phase III trials. Aimovig™, co-developed by Amgen and Novartis, is the first approved migraine treatment targeting the calcitonin gene related peptide (CGRP) pathway, which is causally linked to migraine pains.

Considering the extremely high economic burden of migraines – estimated at 27 billion per year in Europe and $17 billion per year in the USA – and the high prevalence of approximately 15% in Western populations, preventative treatments have been long coveted. In a recent phase III trial, Aimovig™ significantly reduced the number of migraine days and decreased the need for acute pain management. Prophylactic therapies such as Aimovig™ are therefore hoped to ease the economic burden resulting from missed working days and acute pain management, but most of all, these therapies will ease the burden on migraine sufferers.

Aimovig™ comes in the form of a once monthly injectable prized at $575, which sums up to $6,900 per patient per year. The list prize is mercifully below the $8,000-$10,000 spread that Express Scripts, a US prescription benefit plan provider, had warned would be unacceptably high.  

Who will get this new treatment? Acknowledging that there is “a serious unmet need for patients with migraine”, a spokesperson from Express Scripts told Endpoint News: “Not all patients will need this therapy. We see it for people with migraine who have failed preventive therapy. We will ensure appropriate patients have access to this medicine.”


References:

Novartis (2018). Novartis and Amgen announce FDA approval ofAimovig™ (erenumab), a novel treatment developed specifically for migraine prevention. Available at: https://www.novartis.com/news/media-releases/novartis-and-amgen-announce-fda-approval-aimovigtm-erenumab-novel-treatment-developed-specifically-migraine-prevention; accessed May 25, 2018.

Caroll J (2018). Amgen, Novartis ready to roll as FDA green lights blockbuster campaign for migraine drug — priced at $6,900. Endpoint News. Available at: https://endpts.com/amgen-novartis-ready-to-roll-as-fda-green-lights-blockbuster-campaign-for-migraine-drug-priced-at-6900/; accessed May 25, 2018.

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