Following the news that the Food and Drug Administration (FDA) has approved Vyepti for the prevention of migraines in adults, Philippa Salter, Neurology and Ophthalmology Analyst at GlobalData, a leading data and analytics company, offers her view:

“Vyepti becomes the latest FDA approved drug for prevention of migraines in adults, following the approval of Amgen’s Aimovig, Eli Lilly’s Emgality and Teva’s Ajovy all of which were approved in the past two years.

“In order to stand out in this crowded market Lundbeck are drawing attention to the improved dosing schedule of every 12 weeks for Vyepti, which they hope will give it a competitive advantage over the other available drugs which require dosing every four weeks.

“However, GlobalData expects that Vyepti will not become a first-line therapy for migraine prevention, most likely being used for patients who fail on the other already approved medications. This is reflected in the modest sales GlobalData expects for Vyepti of $566m in 2025. In comparison, both Aimovig and Emgality are expected to be blockbuster drugs by 2025 with global sales of $1.8bn and $1.7bn respectively.”

“Vyepti is administered by intravenous infusion which is a much more time consuming and inconvenient route of administration compared with the subcutaneous injection of Vyepti’s competitors. It is expected that the inconvenient administration will outweigh the benefits of a reduced dosing schedule, making it hard for Vyepti to gain traction in this crowded market.”