Patients with difficult-to-treat migraine were randomly assigned 1:1 to either 140 mg erenumab or placebo.
The first-in-class migraine prevention drug will be available to patients within 1 week of the approval.
Researchers assessed the ability of erenumab to decrease the mean number of acute headache days in patients with episodic migraine.
A monthly subcutaneous injection of 70 mg erenumab may represent an effective prophylactic treatment for episodic migraine.
A recent study evaluated the safety and efficacy of erenumab in patients with episodic migraine who had experienced 2 to 4 previous preventive treatment failures, due to lack of efficacy or intolerable side effects.
The monoclonal antibody erenumab has shown favorable results regarding efficacy and safety for the prevention of migraine.
The FDA has accepted for review the Biologics License Application for Aimovig for migraine prophylaxis in patients experiencing more than 4 migraine days per month.
In a phase 3 trial, treatment with erenumab reduced migraine frequency, monthly migraine days, and migraine medication use in patients with episodic migraine.
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