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USFDA approves Amgen drug for prevention of migraines

USFDA approves Amgen drug for prevention of migraines

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

The drug, Aimovig, which is given monthly by self-injection, will have a list price of $6,900 a year, or $575 a month, the company said. Any discounts or rebates will depend on negotiations with health plans, Amgen spokeswoman Kristen Davis said.

Aimovig is the first in a new class of treatments designed 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.

Companies including Teva Pharmaceutical Industries and Eli Lilly & Co are developing similar treatments.

In studies of patients with chronic and episodic migraines, Aimovig was shown to significantly reduce headache days and use of other acute migraine medications.

Some Wall Street analysts had expected Amgen to price Aimovig as high as $10,000 a year.

Analysts, on average, have forecast annual Aimovig sales of nearly $1 billion by 2022, according to Thomson Reuters I/B/E/S.

Express Scripts, the largest U.S. manager of prescription benefits, has called for Amgen to reconsider its strategy of setting a high list price for new drugs and then lowering the cost for health plans through hefty rebates.

Amgen, which will market Aimovig in partnership with Novartis, said the drug’s price “reflects the value it brings to patients and society.” The company said it will pay most out-of-pocket costs for eligible patients with commercial insurance.

(Reporting by Deena Beasley; Editing by Sandra Maler and Leslie Adler)

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