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Published: Sun, May 20, 2018
Economy | By Melissa Porter

Novel Preventive Migraine Treatment Gains FDA Approval

Novel Preventive Migraine Treatment Gains FDA Approval

In a statement, Novartis said the Federal Drug Administration approved Aimovig's use for the preventive treatment of migraines in adults.

Another plus for patients could be the method of administration - Aimovig is delivered via an insulin-style injector pen just once a month.

"Aimovig provides patients with a novel option for reducing the number of days (spent suffering) with migraine", said Eric Bastings, deputy director of the division of neurology products in the FDA's Center for Drug Evaluation and Research.

Amgen and partner Novartis AG said that they will launch the drug within one week in the U.S. Hooper said that the company expects patients will take the drug if they have tried and failed on other migraine treatments. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy - with a discontinuation rate of 2% percent due to adverse events - and experienced sustained migraine prevention". The treatment is given by once-monthly self injections.

In Europe, migraine sufferers will have to wait a little longer for access to the drug, with the EMA due to complete its ongoing review of Aimovig in the next few months.

Aimovig and the migraine drugs in development target a substance called CGRP whose levels spike in the blood during a migraine, triggering symptoms.

Teva's fremanezumab and Eli Lilly and Co.'s galcanezumab are both awaiting a decision, and Alder's eptinezumab NDA is expected later this year. There is a need to add more treatment plans for this painful and often debilitating condition.

Lilly's combined studies evaluated more than 340 patients, representing the largest controlled preventive trials conducted in cluster headache to date. This drug is the first in its class to get FDA approval. Specifically, during the 12-week period after the first dose, monthly migraine days were significantly reduced to 4.6 days for monthly (p 0.001) and 4.9 days for quarterly (p 0.001) dosing compared with 5.9 days for placebo, according to the company's release.

The second three-month trial included 577 episodic migraine patients, where patients experienced on average one fewer migraine day per month than those on placebo.

Amgen shares advanced 0.5 percent to $175.50 at 9:56 a.m.in NY.

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