FDA greenlights Teva’s migraine drug Ajovy in two dosage options
pharmafile | September 20, 2018 | News story | Sales and Marketing | FDA, Teva, US, ajovy, migraine, pharma
Israeli drugmaker Teva has announced that its calcitonin gene-related peptide (CGRP) inhibitor Ajovy (remanezumab-vfrm) has received FDA approval as a preventative treatment for migraine in both monthly and quarterly doses.
The drug, which the manufacturer claims is the first of its kind to secure approval across the two dosing groups, reduced monthly migraine days experienced by participants with disabling migraine over 12 weeks, both as a monotherapy and in combination with oral preventative treatments.
“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” commented Dr Stephen Silberstein, Director, Jefferson Headache Center at Thomas Jefferson University Hospital, and lead investigator of the Phase III clinical trial programme for Ajovy. “About 40% of people living with this condition may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”
Ajovy’s wholesale acquisition cost in the US stands at $575 for a monthly dose and $1,725 for a quarterly dose, and will be made available in just over a week’s time.
Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva, added: “Today’s approval is an important step forward for Teva and the migraine community. Our entire organisation is proud to bring this new biologic product forward at a responsible price, and we are eager to work with insurers to encourage coverage that provides full access and availability in this much needed category.”
Matt Fellows
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