Amgen and Novartis' Aimovig has become the first anti-CGRP therapy to win regulatory clearance in the U.S., winning approval for migraine prevention.
Aimovig blocks the calcitonin gene-related peptide receptor (CGRP-R), which is considered to play an important role in migraine.
As a migraine treatment Botox costs around $3,500 per year, and analysts predict that the annual price for Aimovig will drop to around $5,000 with rebates and discounts.
Tareck Kadrie, a neurologist in a private practice in Chattanooga, Tennessee, told The Wall Street Journal: "We think it's going to revolutionize treatment in migraines".
Erenumab is the first CGRP antagonist to be approved by the FDA for migraine prevention in adults.
The drug offers new hope for the around 39 million adults and children in the USA who deal with migraines, which are characterized by an intense, pulsing or throbbing pain in one side of the head.
Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area of the head.
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Results show that patients taking the drug had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo, with more than twice as many patients taking Aimovig achieving this reduction (30.3 percent versus 13.7 percent, respectively).
People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, hormonal changes, bright or flashing lights, lack of food or sleep and diet.
The drug, Aimovig, made by Amgen and Novartis, is a monthly injection with a device similar to an insulin pen. It will cost $6,900 annually.
The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo. Over the course of six months, those who used Aimovig experienced one to two fewer migraines per month.
After successful and safe clinical trials, the FDA has approved a first-of-its-kind migraine preventative medicine.
The most common side effects that patients in the clinical trials reported were injection site reactions and constipation.
According to Beatings, a large number of people requires new methods to treat migraine headaches, which is a debilitating condition in which significantly reduced human activity. In a third, three-month study on nearly 670 patients with chronic migraines, patients experienced on average 2.5 fewer monthly migraines.