- 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
Click here to read full press release/ article | Ref: GSK | Image: Outsourcing Pharma