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FDA approves new migraine drug

Amgen Inc has won approval from the US Food and Drug Administration for the first drug in a new class designed to prevent migraine headaches in adults. Reuters Health reports that the drug, Aimovig, which is given monthly by self-injection, will have a list price of $6,900 a year, or $575 a month, the company said. Any discounts or rebates will depend on negotiations with health plans, Amgen spokesperson Kristen Davis said.

The report says Aimovig is the first in a new class of treatments designed to prevent migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off the severe headaches, such as dilation of blood vessels in the brain. Companies including Teva Pharmaceutical Industries, Eli Lilly & Co and Alder Biopharmaceuticals Inc are developing similar treatments.

Preventive medications may be an option for around 8m Americans suffering from migraines, Amgen said.

In three separate pivotal trials, involving patients with chronic or episodic migraines, patients given Aimovig experienced an average of one to 2.5 fewer migraine days a month than those treated with a placebo, the FDA said.

The most common side effects reported by patients in the trials were injection site reactions and constipation.

The report says current migraines treatments are mostly repurposed generic drugs including anti-depressants and hypertension medicines. Allergan’s anti-wrinkle injection Botox is approved for patients suffering from 15 or more migraine headaches a month.

Amgen, which will market Aimovig in partnership with Novartis, said the drug’s price “reflects the value it brings to patients and society.” The company said it will pay most out-of-pocket costs for eligible patients with commercial insurance.

[link url=""]Reuters Health report[/link]

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