Merck Gets FDA Priority Review of Dificid in Children

Date : 10/02/2019 @ 11:32AM
Source : Dow Jones News
Stock : Merck and Co Inc (MRK)
Quote : 84.82  0.7 (0.83%) @ 10:05PM
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Merck Gets FDA Priority Review of Dificid in Children

Merck (NYSE:MRK)
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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.

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