FDA approves Amgen drug for prevention of migraines

FDA approves drug to prevent migraines

Amgen, which will market Aimovig in partnership with Novartis, said the drug's price "reflects the value it brings to patients and society". It will cost $6,900 a year.

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

In a statement on Thursday, Express Scripts said migraine patients have a serious unmet need, but "not everyone will need this drug" and it will have a program in place to make sure the medication is authorized for only the appropriate patients.

CGRP isn't exactly a new target. CGRP has been known to play a significant role in migraines since the 1980s and 1990s, though it's taken some time to develop the technology that can leverage it.

The drug, called Aimovig, produced by pharmaceutical giants Amgen and Novartis, is meant to be administered through a monthly injection, and would cost patients $6,900 annually, Amgen said.

Aimovig is one of a handful of preventive migraine drugs, with a handful also in front of the FDA for review. Eli Lilly is lined up as the second entry to the CGRP space in a matter of months, with familiar data on its ability to significantly cut the number of migraines chronic sufferers have to endure. The company found in two studies that patients on the drug had between a 3.6 and 4-day reduction in migraine days per month (to be eligible, patients had to have between 4 and 14 migraine days per month). On average, the trial participants had 9.1 migraine days. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy - with a discontinuation rate of 2% percent due to adverse events - and experienced sustained migraine prevention".

Alder Biopharmaceuticals, eptinezumab- Alder's drug, which would be administered on a quarterly basis, succeeded in phase 3 trials, the company said in January. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials.

The Food and Drug Administration's action clears the monthly shot Aimovig (AIM'-oh-vig) for sale. 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.

Steve Miller, chief medical officer of Express Scripts, had raised a warning flag on this drug, trying to steer the companies away from a high wholesale price, which would be used to set out-of-pocket costs for consumers and a high-water mark for payers to discount against.

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