www.fdanews.com/articles/188438-fda-approves-new-migraine-treatment
FDA Approves New Migraine Treatment
September 18, 2018
The FDA approved Teva Pharmaceuticals’ migraine treatment Ajovy (fremanezumab) three months after putting the brakes on the drug over one of the company’s subcontractor’s plants.
Ajovy, a monoclonal antibody delivered by either monthly or quarterly injections, had successfully completed two separate Phase III trials enrolling some 838 migraine sufferers beginning in November, 2017.
But approval was stalled three months ago after the FDA cited Korean manufacturing company Celltrion for various problems in its factory.
Teva said Ajovy will sell for $575 per month.