FDA approves drug to prevent migraines

The FDA has approved the first drug to prevent migraines

FDA approves Amgen migraine drug, price set at $6900 per year

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

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 the severe headaches, such as dilation of blood vessels in the brain.

And while there aren't any drugs available today that were originally approved for alleviating migraines, other treatments - including Botox and anti-seizure medications- are used.

Preventive medications may be an option for around eight million Americans suffering from migraine, Amgen said.

The drug blocks a protein fragment called CGRP, which is believed to play a critical role in migraines, the company said.

Aimovig is one of a handful of preventive migraine drugs, with a handful also in front of the FDA for review.

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.

Erenumab consistently demonstrated an ability to reduce monthly migraine days in patients with episodic and chronic migraine in 3 major clinical trials, ARISE, STRIVE, and LIBERTY.

Lilly, galcanezumab - Lilly presented phase 3 data in June. "Through educational programs and initiatives, we hope to promote more meaningful connectivity and dialogue among patients, physicians, employers and payers". In the placebo arm, there was just a 0.2-day reduction. "We have pledged a mission to help change misconceptions, stereotyping and even judgment that people with migraine face on a daily basis".

A 50% or greater reduction in migraine days per month was achieved for almost half of patients treated with erenumab (43.4% and 50.0%) compared with just 26.6% with placebo (P .001). Teva filed with the FDA in October. The company plans to submit to the FDA in the second half of 2018. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials.

The new class of drugs aims to reduce the number of days per month people have migraines. It's also well under the $8,500 figure the Institute for Clinical and Economic Review pencilled in for their review, which they considered too costly for all but the most seriously afflicted.

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.

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