By Chris Wack

 

AstraZeneca (AZN) said Friday that the U.S. Food and Drug Administration has approved the self-administration of Fasenra benralizumab in a pre-filled, single-use auto-injector, the Fasenra Pen.

The pharmaceutical company said 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 company said the safety and tolerability of Fasenra in these trials were consistent with the established profile of the medicine.

AstraZeneca says 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 U.S., EU, Japan and other countries.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

October 04, 2019 07:27 ET (11:27 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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