AMGN Amgen Inc

   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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