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The review follows a Times story reporting a series of issues, including two needles that were left in children during surgery.


May 17, 2018 -- The FDA has approved the first in a new class of migraine drugs that aim to fight painful migraine headaches before they start.

Erenumab (Aimovig) is the first of four new migraine drugs in the pipeline that target calcitonin gene-related peptide (CGRP), a molecule that's produced in nerve cells of the brain and spinal cord.

“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.”

About 39 million Americans live with the throbbing pain and nausea of migraine. More than 4 million of them have at least 15 migraine days each month. Even though many drugs prevent and treat these headaches, migraine symptoms disable 1 in 5 people who get them.

Aimovig is a monoclonal antibody given as a shot for people who have four or more migraine days each month. The FDA evalauted results of three patient studies in making its approval. In those studies, patients on average had one to 2 ? fewer monthly migraine days either over six months or three months.

In a news release, the drug's manufacturer, Amgen, said the list price will be 5 a month or ,900 annually. Costs to patients may vary depending on insurance.

Turning 'the Volume Down' on Migraine

Over years of research, scientists discovered that CGRP helps transmit pain signals in the brain.

"We've believed for a long time that CGRP played a very important role in migraine, and part of the reason we believed that is because when people get a migraine attack, we can measure elevations of CGRP in their blood," says Richard Lipton, MD, director of the Montefiore Headache Center.

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