Amgen gets approval for migraine drug

Henrietta Strickland
May 18, 2018

One in 10 people across the world are afflicted by this ailment.

The drug is administered on a monthly basis via injection. The listing price in the United States is set at US$575 for a single monthly dose (or $6,900 annually).

The approval for sale in the European Union is expected in the next few months.

Express Scripts, the largest USA manager of prescription benefits, has called for Amgen to reconsider its strategy of setting a high list price for new drugs and then lowering the cost for health plans through hefty rebates.

The newly approved drug is erenumab, which is marketed as Aimovig, and it works by blocking calcitonin gene-related peptide receptors (CGRP-R) in the brain. Aimovig is only the first out of the gate.

After successful and safe clinical trials, the FDA has approved a first-of-its-kind migraine preventative medicine.

"Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine", says Paul Hudson, CEO Novartis Pharmaceuticals. The most commonly reported adverse events through all trials have been injection site reactions and constipation. Dr. Eric Bastings being the Deputy head of the Division of neurologic products at FDA, said that with the new drug Aimovig many patients will be able to minimize the days with the headaches.

Current prevention treatments include pills originally developed for epilepsy and other conditions and the wrinkle reducer Botox, but many patients abandon them because they don't help much or cause serious side effects.

Approximately one-third of affected individuals can predict the onset of a migraine because it is preceded by transient sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision.

The attacks are triggered by a number of factors, "including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet".

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