Amgen Snags FDA Approval for Migraine Drug With $6900 Annual List Price
Regulatory News | 18 May 2018 |
Amgen received US Food and Drug Administration (FDA) approval for its Aimovig (erenumab-aooe).
The first FDA-approved migraine prevention drug—administered via a monthly self-injection using the pharmaceutical giant’s SureClick autoinjector device—for use in adult populations falls under a “new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks,” according to a late Thursday FDA announcement.
FDA evaluated results from three clinical trials for the approval of Aimoving 70 mg and 140 mg. More than 3,000 patients suffering from chronic or episodic migraines participated in the studies, with the most commonly reported adverse reactions being injection site reactions and constipation, said Amgen.
The drug—expected to be released in the US within a week—has a list price of $575 per month, or $6,900 annually. According to Amgen, the price “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.”
The first FDA-approved migraine prevention drug—administered via a monthly self-injection using the pharmaceutical giant’s SureClick autoinjector device—for use in adult populations falls under a “new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks,” according to a late Thursday FDA announcement.
FDA evaluated results from three clinical trials for the approval of Aimoving 70 mg and 140 mg. More than 3,000 patients suffering from chronic or episodic migraines participated in the studies, with the most commonly reported adverse reactions being injection site reactions and constipation, said Amgen.
The drug—expected to be released in the US within a week—has a list price of $575 per month, or $6,900 annually. According to Amgen, the price “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.”
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