FDA approves Amgen migraine drug, price set at $6900 per year
18 May, 2018, 16:40
Monthly anti-migraine injections have won US Food and Drug Administration approval, a month after the results of clinical trials were presented at the American Academy of Neurology's annual meeting.
The drug works by blocking a compound called calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine.
"Cluster headache can be hard to evaluate in clinical studies, which has contributed to few available treatment options for clusterheadache, often considered the most severe pain one can experience", noted Christi Shaw, president of Lilly Bio-Medicines, in the release.
In a study, patients who were administered with the Aimovig shot saw that their migraine days were reduced from eight days to four days in a month on an average.
The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo.
In Europe, migraine sufferers will have to wait a little longer for access to the drug, with the EMA due to complete its ongoing review of Aimovig in the next few months.
We remind investors that Eli Lilly (LLY - Free Report) and Teva Pharmaceutical Industries Limited (TEVA - Free Report) also have anti-CGRP candidates, galcanezumab and fremanezumab, respectively, which are under review in the United States. These drugs aim to block it cut down on the number of migraine days patients suffer each month.
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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.
The approval for sale in the European Union is expected in the next few months.
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.
That's compared to the 2.15 and 1.85 day reduction that was observed in the placebo groups.
The most common side effects reported by patients in the trials were injection site reactions and constipation.
Aimovig is a monthly shot that's the first in a new class of anti-migraine treatments, coming at a cost of $6,900 per year without insurance. The Teva CGRP antibody is now under FDA review for preventive migraine in adults.
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