AstraZeneca Inhaler Treatment for Lung Disease Hits U.S. Setback
October 01 2019 - 4:01AM
Dow Jones News
By Carlo Martuscelli
AstraZeneca PLC (AZN.LN) said Tuesday that the U.S. Food and
Drug Administration hadn't approved its new drug application for
PT010, an inhaled treatment for chronic obstructive pulmonary
disease.
The British pharmaceutical company said that the regulator
issued a letter provisionally denying its request to approve the
drug.
Astra said it will now work with the FDA to move the process
forward by providing previously unsubmitted data which wasn't
available when the first application was made.
PT010 was approved in Japan in June under the name Breztri
Aerosphere, and is under regulatory review in China and the
European Union.
Write to Carlo Martuscelli at carlo.martuscelli@dowjones.com
(END) Dow Jones Newswires
October 01, 2019 03:46 ET (07:46 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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