AstraZeneca’s Fasenra Pen (Pre-Filled Auto-Injector) Receives the US FDA’s Approval for Severe Eosinophilic Asthma

AstraZeneca’s Fasenra Pen (Pre-Filled Auto-Injector) Receives the US FDA’s Approval for Severe Eosinophilic Asthma

Shots:

  • 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.

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