Shots:
The marketing authorization is based on the P-III (PROMISE-1 & 2) trial evaluating the efficacy and safety of Vyepti vs PBO in ~2000 patients with migraine
The results showed a reduction in monthly migraine days over PBO & sustained for 12wk. dosing interval and duration of treatment 12 & 6mos. in PROMISE-1 & 2 trial, reduction in the prevalence of migraine (50%) for both doses of Vyepti on day 1 post-infusion & the effects on PROs were observed for ~96 wks.
The marketing authorization is valid in all EU Member States, Iceland, Norway, and Liechtenstein. The therapy was approved in the US for migraine & is expected to be launched in the EU in the coming mos.
Ref: Cision | Image: Medwatch
