Merck, AstraZeneca Get FDA Priority Review for Selumetinib in NF1
November 14 2019 - 7:55AM
Dow Jones News
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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