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AZN Astrazeneca Plc

12,050.00
-106.00 (-0.87%)
03 May 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Astrazeneca Plc LSE:AZN London Ordinary Share GB0009895292 ORD SHS $0.25
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -106.00 -0.87% 12,050.00 12,036.00 12,038.00 12,178.00 12,010.00 12,092.00 1,635,146 16:35:23
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
Pharmaceutical Preparations 45.81B 5.96B 3.8415 31.34 186.61B

AstraZeneca Gets FDA Approval for Fasenra Auto-Injector Pen

04/10/2019 12:42pm

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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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