Merck Gets FDA Priority Review of Dificid in Children
02 Oktober 2019 - 1:32PM
Dow Jones News
By Colin Kellaher
Merck & Co. (MRK) on Wednesday said the U.S. Food and Drug
Administration accepted and granted priority review to a pair of
applications for its antibacterial medicine Dificid to treat
Clostridium difficile infections in children.
The Kenilworth, N.J., drug maker said the priority-review
designations cover a new-drug application for Dificid for oral
suspension and a supplemental NDA for a new indication for the use
of Dificid tablets and oral suspension in children ages six months
or older.
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.
The agency set a target action date of Jan. 24, 2020, for both
applications, Merck said.
Clostridium difficile, also known as C. difficile, is one of the
most common causes of healthcare-associated infections in U.S.
hospitals, Merck said, adding that evidence shows an increasing
incidence of C. difficile-associated diarrhea among hospitalized
children.
Dificid is currently approved to treat C. difficile-associated
diarrhea in patients ages 18 years older.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 02, 2019 07:17 ET (11:17 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Merck (NYSE:MRK)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
Von Apr 2023 bis Apr 2024
