Historical Stock Chart
3 Months : From Sep 2019 to Dec 2019
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 firstname.lastname@example.org
(END) Dow Jones Newswires
October 04, 2019 07:27 ET (11:27 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.