The US FDA has approved the self-administration of Fasenra (benralizumab) in a pre-filled- single-use auto-injector- based on P-III GRECO and P-I AMES study
The P-III GRECO study involves assessing of Fasenra Pen with Fasenra (FD- 30mg- SC- q4w) in 120 patients with severe- uncontrolled asthma resulted in a 97% success rate of self-administration @12 & 16wks. The P-I AMES study compares the PK exposure following Fasenra (SC-30mg) in healthy people by using a pre-filled syringe or pre-filled auto-injector devices
Fasenra is the AstraZeneca’s first respiratory biologic (mAb) targeting IL-5 receptor alpha on eosinophils and attract NK cells to induce depletion of eosinophils via apoptosis and is approved as add-on maintenance treatment for SEA in the US- EU- Japan & other countries.
Click here to read full press release/ article
Ref: AstraZeneca | Image:AstraZeneca
