AstraZeneca, Amgen Drug Given Green Light for Expedited Review by U.S. FDA
September 07 2018 - 2:48AM
Dow Jones News
By Carlo Martuscelli
AstraZeneca PLC (AZN.LN) said Friday that its tezepelumab drug,
which it is developing with Amgen Inc. (AMGN), was granted
breakthrough therapy designation by the U.S. Food and Drug
Administration.
The FDA awarded the designation to tezepelumab for treatment of
patients with severe asthma--without an eosinophilic phenotype--who
are receiving inhaled steroids or long-acting beta2-agonists.
The designation allows a treatments for severe conditions to
pass through development and regulatory review more quickly, and is
granted when there are clinical results that suggest it is
substantially more effective than other medicine.
AstraZeneca said that the breakthrough therapy designation was
given based on the results of the Pathway phase 2 study that showed
a significant reduction in asthma exacerbation rate in a broad
population of patients.
Write to Carlo Martuscelli at carlo.martuscelli@dowjones.com
(END) Dow Jones Newswires
September 07, 2018 02:33 ET (06:33 GMT)
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