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First migraine prevention drug to hit European market

European Commission green lights Novartis’ Aimovig


In what will be a first for Europe, patients who experience four or more days of migraine episodes per month will soon be able to access Novartis’ migraine prevention treatment Aimovig.

The European Commission (EC) approved the novel treatment yesterday after it received a positive recommendation from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last month.

The committee evaluated Aimovig’s safety and efficacy from a 2,600-patient-enrolled clinical programme, and it was found to have a safety and tolerability profile similar to placebo.

It was reported that those on Aimovig also experienced significant reductions in their number of migraine days per month.

Additionally, following an interim analysis from a five-year open label extension in episodic migraine, Aimovig also demonstrated that more than one in four (26%) patients on the treatment were completely migraine free after 15 months.

Paul Hudson, chief executive officer of Novartis, said: “Today's approval is ground breaking for people living with migraine, their families and doctors.

“In clinical trials, Aimovig has consistently shown to be effective in preventing migraine and bringing relief from the grip of this disease.

“We are proud to be the first to reimagine migraine prevention and we are committed to ensuring Aimovig’s availability for those who could benefit from it.”

Aimovig, which is cleared as a once-monthly, self-injected treatment, operates by blocking the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in mediating the debilitating pain of migraine.

The treatment is already approved in the US, where it is co-commercialised by Novartis and Amgen, the latter of which has exclusive rights to launch the drug in the Japanese market.

Hudson added: “We are launching a tailored post-approval access programme and are exploring a number of innovative reimbursement and access approaches, including paying only for patients who respond well to treatment.”

The treatment seems to be off to a promising start, storming well ahead of rival treatments from Eli Lilly’s galcanezumab, Teva’s fremanezumab and Alder's eptinezumab.

Article by
Gemma Jones

31st July 2018

From: Regulatory



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