U.S. approves new drug for prevention of migraines

U.S. approves new drug for prevention of migraines

"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.

"Aimovig provides patients with a novel option for reducing the number of days with migraine", Dr. Eric Bastings, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in the statement.

Aimovig is expected to be available to patients in the USA within one week.

Aimovig is the first in a new class of treatments created to prevent migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off a migraine, such as dilation of blood vessels in the brain. It will cost US$6,900 a year. About 10 million Americans get them frequently. But it's known well among the migraine-afflicted that there is not medicine to treat or prevent these severely debilitating episodes that some patients can see coming.

Until now, drugs used to prevent migraines were created to treat other diseases, like high blood pressure.

Tepper and Starling, like most leading migraine specialists, have consulted with the drug companies and enrolled patients in their clinical trials.

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That's compared to the 2.15 and 1.85 day reduction that was observed in the placebo groups. Lilly is expecting the FDA to complete its review of galcanezumab in the third quarter.

The approval for sale in the European Union is expected in the next few months. On average, the trial participants had 9.1 migraine days.

The first study involved nearly 1,000 participants. Teva filed with the FDA in October.

Aimovig is just one of four different treatments now in development that target CGRP receptors. He described it as the "first treatment directed toward migraine prevention". The co-pay burden is one of the key targets in President Trump's blueprint to lower drug prices in the US.

Alder's eptinezumab is a slightly different proposition because it is given by infusion every three months for prevention - while the other three CGRPs are all given by subcutaneously - and its delivery route means it is also being tested as an acute migraine treatment.

This article was originally published by Business Insider.

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