Amgen has received approval from the US Food and Drug Administration (FDA) for its Aimovig drug as a preventive treatment for migraine in adults.
The therapy has been developed by Amgen under neuroscience collaboration with Novartis.
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By GlobalDataAimovig is designed to prevent migraines by inhibiting the calcitonin gene-related peptide receptor (CGRP-R) that is believed to be involved in causing the condition.
The indication covers 70mg Aimovig to be self-administered once monthly using Amgen’s SureClick autoinjector device and does not need a loading dose. Certain patients may benefit with 140mg dosage.
Amgen Research and Development executive vice-president Sean Harper said: “Migraine patients experience excruciating headache pain, often accompanied by other symptoms such as nausea and vomiting, and many live in constant dread of the next attack.
“The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine.”
When compared to placebo in Phase II and III clinical trials for chronic and episodic migraine, Aimovig is reported to have demonstrated a significant decrease in the number of migraine days per month and use of acute medications.
These effects on monthly migraine days were found to be sustained for about 15 months in an ongoing open-label extension study for episodic migraine treatment.
During a Phase IIIb trial with difficult-to-treat populations, Aimovig is said to have had almost three times higher odds of reducing migraine days by 50% or more, when compared to placebo.
The efficacy, tolerability and safety of the drug have been evaluated in a total of more than 3,000 patients, with injection site reactions and constipation being the most common adverse reactions.
Amgen and Novartis expect the already submitted marketing authorisation application (MAA) for Aimovig to gain approval from the European Medicines Agency (EMA) over the coming months.
