US FDA approves new drug for prevention of migraines

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

The drug, Aimovig, belongs to a class called anti-CGRP drugs, short for calcitonin gene-related peptide receptor.

On Thursday, the US regulators approved the use of first drug, Aimovig, which has been designed as a preventive treatment for chronic migraines in people.

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Amgen made a statement where they mentioned that the new drug Aimovig is expected to be available to the local people within a week or less and is listed at the price of $6,900 annually.

The FDA's approval of Aimovig (erenumab-aooe) was based on data from three clinical trials - the first involved 955 participants with a history of episodic comparing Aimovig with placebo.

Companies including Teva Pharmaceutical Industries, Eli Lilly & Co, and Alder Biopharmaceuticals Inc are developing similar treatments. In the second (n=577) and third (n=667) studies, in which patients had a history of chronic migraine, subjects experienced one fewer migraine day and 2-1/2 fewer migraine days, per month on average, respectively.

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Amgen Inc. of Thousand Oaks, California, and Swiss drug giant Novartis AG developed Aimovig. The companies expect approval in the European Union in the coming months. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials. Specifically, during the 12-week period after the first dose, monthly migraine days were significantly reduced to 4.6 days for monthly (p 0.001) and 4.9 days for quarterly (p 0.001) dosing compared with 5.9 days for placebo, according to the company's release.

Injection site reactions and constipation were the most common adverse reactions in clinical studies of Aimovig.

They can be debilitating, and are one of the most disabling illness in the world, the Migraine Research Foundation reports. "Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success", said Stewart Tepper, professor of Neurology at the Geisel School of Medicine at Dartmouth Medical School.

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While out-of-pocket costs will vary depending on insurance status, the Aimovig Copay Program may be able to help reduce a patient's out-of-pocket costs to as little as USD5 per month for eligible patients with commercial insurance.

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