Merck & Co. Inc. (NYSE: MRK) has just announced that the U.S. Food and Drug Administration (FDA) accepted a couple New Drug Applications (NDAs) for review.
Specifically, the FDA accepted an NDA for Dificid (fidaxomicin), and a supplemental NDA (sNDA) for a new indication for use of Dificid for the treatment of Clostridium (also known as Clostridioides) difficile infections in children aged six months or older.
Both applications have received a priority review classification by the FDA. The Prescription Drug User Fee Act (PDUFA), or target action, date for both applications is set for Jan. 24, 2020. The investigational pediatric indication for Dificid was granted Orphan Drug Designation in 2010.
The sNDA is based primarily on results of the Phase 3 Sunshine study, which were presented as part of the Late Breaker Oral Abstracts on Emerging Infections at IDWeek 2018 in San Francisco, California.
Dr. Nicholas Kartsonis, senior vice president, Clinical Research, infectious diseases and vaccines, Merck Research Laboratories, commented:
Evidence indicates the increasing incidence of C. difficile-associated diarrhea among hospitalized children. The filings for the pediatric indication for the new investigational oral suspension formulation of DIFICID, as well as for Dificid tablets, underscore Merck’s focus and dedication to developing infectious disease treatments for those with unmet needs.
Note that Clostridium difficile, also known as C. difficile or C. diff, is one of the most common causes of health-care-associated infections in U.S. hospitals. Recent estimates suggest C. difficile causes almost 500,000 infections annually in the United States and is associated with roughly 29,000 deaths within 30 days of initial diagnosis.
Shares of Merck traded at $83.61 on Wednesday, in a 52-week range of $66.10 to $87.35. the consensus price target is $96.33.