The approval is supported by data from the Phase III GRECO trial and the Phase I AMES trial, which achieved their primary objective of usability and pharmacokinetic exposure, respectively. The safety and tolerability of Fasenra in these trials were consistent with the established profile of the medicine.
Fasenra self-administration and the Fasenra Pen are also approved in the European Union. Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries.
Fasenra is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of Fasenra.
These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.
The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
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