AstraZeneca Gets FDA Approval for Fasenra Auto-Injector Pen
October 04 2019 - 7:42AM
Dow Jones News
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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