Published: Fri, May 18, 2018
Medicine | By Earnest Bishop

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

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

Shares of drugmakers Amgen Inc. and Novartis AG rose in after-hours trading Thursday after jointly announcing FDA approval of Aimovig, a first-of-its-kind treatment for migraines. "Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine", Novartis Chief Executive Paul Hudson said in the statement.

According to Beatings, a large number of people requires new methods to treat migraine headaches, which is a debilitating condition in which significantly reduced human activity.

In Europe, migraine sufferers will have to wait a little longer for access to the drug, with the EMA due to complete its ongoing review of Aimovig in the next few months.

Results show that patients taking the drug had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo, with more than twice as many patients taking Aimovig achieving this reduction (30.3 percent versus 13.7 percent, respectively).

Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide.

Another plus for patients could be the method of administration - Aimovig is delivered via an insulin-style injector pen just once a month.

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FDA approves Aimovig (erenumab-aooe), a novel treatment developed specifically for migraine prevention [press release]. The co-pay burden is one of the key targets in President Trump's blueprint to lower drug prices in the US.

Amgen Inc is also in collaboration with the Swiss pharmaceutical firm Novartis that can help in commercializing the medication rapidly and across the globe. However, there were side-effects too - namely injection-site reactions and constipation.

In addition to painkillers and triptans, which ease migraine effects when taken after one starts, preventative treatments for migraines already exist in the form of blood-vessel constrictors and Botox treatments. Lilly and Teva weren't yet active. In this study, over the course of three months, patients treated with Aimovig experienced, on average, two and half fewer monthly migraine days than those receiving placebo.

That's compared to the 2.15 and 1.85 day reduction that was observed in the placebo groups.

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.

The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo.

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