BASEL (dpa-AFX) - Amgen (AMGN) announced that the U.S. Food and Drug Administration has approved Aimovig or erenumab-aooe for the preventive treatment of migraine in adults. Aimovig is expected to be available to patients within one week.
Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R) - which is believed to play a critical role in migraine.
Aimovig 70 mg is self-administered once monthly via Amgen's device, the SureClick autoinjector, and does not require a loading dose. Some patients may benefit from a dosage of 140 mg once monthly.
In Phase 2 and 3 studies in chronic and episodic migraine, Aimovig resulted in significant reductions in monthly migraine days and use of acute migraine medications compared to placebo. These effects on monthly migraine days have been shown to be sustained for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days per month).
Amgen and Novartis are committed to supporting the migraine community and to helping appropriate patients with affordable access to Aimovig.
The U.S. list price of Aimovig is $575 for once monthly 70 or 140 mg single-use prefilled SureClick autoinjector(s), or $6,900 annually. The price of Aimovig reflects the value it brings to patients and society, including the financial impact on sufferers, caregivers and employers, while also factoring in critical issues such as patient affordability, and fair and timely access.
While out-of-pocket costs will vary depending on insurance status, the Aimovig Copay Program may be able to help reduce a patient's out-of-pocket costs to as little as $5 per month for eligible patients with commercial insurance.
The European Medicines Agency (EMA) Marketing Authorization Application for Aimovig is under review. The companies expect approval in the EU in the coming months.
Copyright RTT News/dpa-AFX