FDA approves preventative treatment for migraines


The drug named, Aimovig is given on a monthly basis by self-injections and will be priced at United States dollars 6,900 annually or USD 575 monthly.

The two partners say they intend to launch Aimovig within a week, and have given it a list price of $6,900 per year - or $570 per month - which is well below earlier predictions of an $8,000-$10,000 annual price range.

The treatment is given by monthly self-injections.

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.

The monoclonal antibody offers patients a novel therapeutic approach as the first to block the calcitonin gene-related peptide receptor (CGRP-R), which is thought to play a critical role in migraine. "This is really an unbelievable time for my patient population and for general neurologists treating patients with migraine".

Lilly presented phase 3 data in June.

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

The drug has been under review in the European Union since June a year ago, and Novartis says it expected approval in there "in the coming months". On average, the trial participants had 9.1 migraine days. Teva filed with the FDA in October.

US President Donald Trump last week blasted drugmakers and healthcare "middlemen" for making prescription medicines unaffordable for Americans as the administration said it would act to boost competition between pharmaceutical companies and test ways to pay for drugs based on their effectiveness.

Three other companies with matching medicines that use the same molecule blocker have also reached the final stages of the FDA's approval process. He described it as the "first treatment directed toward migraine prevention". In three clinical trials on individuals with a history of episodic migraines, it was shown to be better than a placebo in lowering the onset of migraines.

Aimovig and the migraine drugs in development target a substance called CGRP whose levels spike in the blood during a migraine, triggering symptoms.

This article was originally published by Business Insider.