Shots:

• The approval is based on pivotal P-III study assessing Nucala (300mg- SC- q4w) + SOC vs PBO + SOC in 108 patients aged ≥12yrs.with uncontrolled HES for 32 wks.
• Results: The pivotal P-III study demonstrated 50% fewer patients experienced a HES flare 28% vs 56%). The approval follows a PR of data from a clinical development program that included positive results from a pivotal P-III study
• Mepolizumab is a mAb targeting IL-5- it works by preventing IL-5 from binding to its receptor on the surface of eosinophils- reducing blood eosinophils to normal levels & it is first approved in 2015 for severe eosinophilic asthma

­ Ref: GSK | Image: GSK