FDA approves mepolizumab (Nucala) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES)
Approval was based on a double-blind, multicentre RCT (N=108) which found a 50% relative reduction in HES flares vs placebo over 32 weeks (28% vs 56%) with a later time to the first HES flare.
Source:
Biospace Inc.
SPS commentary:
In the UK, mepolizumab is currently licensed as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.