US FDA approves Amgen drug for prevention of migraines

1819 A man suffering from a headache is tormented by a horde of little demons. 'Headache' by Cruikshank

1819 A man suffering from a headache is tormented by a horde of little demons. 'Headache' by Cruikshank

The US Food and Drug Administration approval for the first drug to prevent migraine headaches in adults has been won by Amgen Inc.

Amgen said that it expects to make the drug available to patients in the USA within a week.

The price is valid for 70 milligrams and a 140 mg dose.

The drug has been evaluated in more than 3000 patients, and its efficacy, tolerability, and safety continue to be examined in an ongoing 5-year open-label extension study.

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.

U.S. President Donald Trump last week blasted drugmakers and healthcare "middlemen" for making prescription medicines unaffordable for Americans as the administration said it would act to boost competition between pharmaceutical companies and test ways to pay for drugs based on their effectiveness.

"Having a treatment created to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine", said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School in New Hampshire, in a statement. Trials of the medication showed many patients experiencing at least a 50 percent reduction in the number of days they experienced a migraine.

Current migraine treatments are mostly repurposed generic drugs including anti-depressants and hypertension medicines.

Amgen, which will market Aimovig in partnership with Novartis, said the drug's price "reflects the value it brings to patients and society".

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