GSK’s Nucala (mepolizumab) Receives FDA’s Approval for its Two New Self-Administered Methods for Patients with SEA and EGPA

GSK’s Nucala (mepolizumab) Receives FDA’s Approval for its Two New Self-Administered Methods for Patients with SEA and EGPA

Shots:

  • The approval is based on P-IIIa studies (NCT03099096 & NCT03021304) assessing Nucala in-clinic and at home for patients with severe eosinophilic asthma (SEA). Additionally, a study (NCT03014674) evaluated Nucala’s PK and PD via auto-injector & pre-filled syringe was comparable with approved lyophilised formulation
  • The study resulted in 89-95% and 100% successful self-administered treatment with autoinjector and pre-filled syringe respectively post training of patients
  • Nucala is a mAb that targets interleukin-5 (IL-5) available as an autoinjector/pre-filled syringe administered q4w and is approved in EU for pediatric patients aged 6 to 17 yrs. for SAE and in the US, Japan & Canada as an add-on maintenance treatment for EGPA

Click here to read full press release/ article | Ref: GSK | Image: Xtra Shot