A new medicine that is created to prevent the onset of a migraine was approved by the Food and Drug Administration on Thursday.
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.
"The FDA approval of Aimovig demonstrates Novartis commitment to bringing meaningful new medicines to patients with complex neurologic diseases, like migraine", said Paul Hudson, who heads Novartis pharma division said in the company's press release.
The drug is expected to be available in the USA within a week, with a list price of $575 for once monthly 70mg or 140mg single-use prefilled SureClick autoinjectors, or $6,900 annually.
The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo.
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"Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy - with a discontinuation rate of two percent due to adverse events - and experienced sustained migraine prevention".
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).
Novartis and Amgen seem to have heeded warnings that healthcare payers may baulk at covering the drug if the price was set too high.
The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials. The companies expect approval in the European Union in the coming months.
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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.
The effects on monthly migraine days were shown to be continued for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days a month).
They can be debilitating, and are one of the most disabling illness in the world, the Migraine Research Foundation reports. It is expected to be made available in the US within a week's time.
New treatment options, specifically developed to treat migraine, are making their way, suggesting potential demand for Aimovig. Each patient group had similar minor side effects, mostly colds and respiratory infections.
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