FDA approves new drug for persistent headache

Drug To Prevent Chronic Migraine Gets FDA Approval

FDA approves new drug for persistent headache

It is the first to reach the market and gives migraine sufferers hope that science has finally found a way to treat what has always been a frustratingly untreatable condition.

A new medicine that is created to prevent the onset of a migraine was approved by the Food and Drug Administration on Thursday.

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.

The drug is expected to be available in the USA within a week, with a list price of $575 for once monthly 70mg or 140mg single-use prefilled SureClick autoinjectors, or $6,900 annually. 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.

The new treatment, a monthly injection, is called Aimovig.

At the heart of this problem is an unresolved conflict between the business of pharmaceuticals driven by the discovery of new drugs through expensive research and the social and moral responsibility felt by emerging economies such as India to extend affordable medicine to all.

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As a recent editorial in the journal JAMA put it, they are "progress, but not a panacea".

Erenumab is the first of 3 anti-CGRP drugs now under review to cross the FDA finish line. The side effects over the long term and among people with chronic diseases remain to be determined. "They will change the way we treat migraine".

Results show that patients taking the drug had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo, with more than twice as many patients taking Aimovig achieving this reduction (30.3 percent versus 13.7 percent, respectively).

While out-of-pocket costs will vary depending on insurance status, the Aimovig Copay Program may be able to help reduce a patient's out-of-pocket costs to as little as USD5 per month for eligible patients with commercial insurance.

About 2 percent of the global population copes with chronic migraines.

Many migraine sufferers report symptoms including intense or pulsing pain, as well as nausea and acute sensitivity to light and sound. The headache can be throbbing and last for hours or days. About 10 million Americans get them frequently. Treating these people has been challenging, doctors say. Drug side effects are frequent and include mental fogginess, sedation, weight gain, sexual dysfunction and dry mouth leading to cavities.

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