The FDA approved a prophylactic for migraines

FDA одобрила профилактические средства от мигрени

The Food and Drug Administration's action clears the monthly shot Aimovig for sale.

Aimovig is the first in a clutch of four calcitonin gene-related peptide (CGRP) drugs to be approved by the FDA.

Amgen Inc won U.S. Food and Drug Administration approval on Thursday for the first drug in a new class created to prevent migraine headaches in adults.

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.

FDA approves Aimovig (erenumab-aooe), a novel treatment developed specifically for migraine prevention [press release].

Amgen and Novartis have beaten Lilly's galcanezumab, Teva's fremanezumab and Alder's eptinezumab to market, with first-mover advantage in a market for CGRP drugs that is expected to grow from zero to $4bn or more by 2026. 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. But it's known well among the migraine-afflicted that there is not medicine to treat or prevent these severely debilitating episodes that some patients can see coming. However, most of the migraine patients avoid using these treatments as they do not help them get enough relief or tend to cause severe side effects.

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The two companies, Novartis and Amgen, are also collaborating on associated "The Aimovig Ally Product Support Program".

In addition, participants reporting ≥ 50% reduction in the monthly average number of migraine days achieved significantly greater results in monthly (47.7%, P 0.001) and quarterly (44.4%, P 0.001) dosing compared with placebo (27.9%).

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. Researchers say CGRP plays an important role in migraines.

In fact, 85 percent of migraine patients stop taking drugs for the disorder within a year.

Aimovig is the first in a new class of treatments created to prevent a 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.

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