Merck, AstraZeneca Get FDA Priority Review for Selumetinib in NF1

Date : 11/14/2019 @ 12:55PM
Source : Dow Jones News
Stock : AstraZeneca PLC (AZN)
Quote : 45.07  -2.5 (-5.26%) @ 1:00AM
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Merck, AstraZeneca Get FDA Priority Review for Selumetinib in NF1

Merck (NYSE:MRK)
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By Colin Kellaher

 

Merck & Co. (MRK) and AstraZeneca PLC (AZN) Thursday said the U.S. Food and Drug Administration accepted and granted priority review to their new-drug application for selumetinib in the rare and incurable genetic condition neurofibromatosis type 1, or NF1.

The drug makers said the NDA covers selumetinib as a potential new medicine for children ages three years and older with NF1 and symptomatic, inoperable plexiform neurofibromas.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months. Merck and AstraZeneca said the agency set a target action date for the second quarter of 2020.

AstraZeneca and Merck in 2017 formed a collaboration to develop and commercialize certain oncology products, including selumetinib.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 14, 2019 07:40 ET (12:40 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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