FDA Approves Merck’s Dificid (fidaxomicin) to Treat Clostridioides

In continuation of my update on fidaxomicin

Merck (NYSE: MRK), known as MSD outside the United States and Canada,  announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Dificid (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older. 

Dificid is a macrolide antibacterial medicine indicated in adults and pediatric patients aged 6 months and older for treatment of CDAD. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dificid and other antibacterial drugs, Dificid should be used only to treat infections that are proven or strongly suspected to be caused by Clostridioides difficile (C. difficile). Dificid is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in Dificid. Dificid should only be used for the treatment of CDAD. Dificid is not expected to be effective for treatment of other types of infections due to minimal systemic absorption of fidaxomicin.

“C. difficile is an important cause of health care- and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized controlled trial of C. difficile infection treatment in children,” said Dr. Larry K. Kociolek, Associate Medical Director of Infection Prevention and Control at Ann & Robert H. Lurie Children’s Hospital of Chicago. “I am very excited to have a new C. difficile infection treatment option for my pediatric patients.”

“Merck is committed to developing new treatments, as well as expanding indications of existing ones, in order to provide more solutions to treat infectious diseases, particularly among children,” said Dr. Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. “C. difficile infection is an urgent public health challenge. We are grateful to the health care practitioners, the patients and their families for their invaluable contributions in helping to bring this new pediatric indication and the oral suspension formulation for Dificid to the U.S. market.”

Both applications received a priority review classification by the FDA. The investigational pediatric indication for Dificid was granted Orphan Drug Designation in 2010.

https://en.wikipedia.org/wiki/Fidaxomicin

FDA Approves Merck’s Dificid (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older

Positive results from second phase 3 Study of Fidaxomicin for the treatment of Clostridium difficile Infection..

Fidaxomicin  is the first in a new class of narrow spectrum macrocyclic  antibiotic drugs.  It is non-systemic (minimally absorbed into the bloodstream)  bactericidal, and  has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the multiple species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of clostridium difficile infection recurrence.

Now Optimer Pharmaceuticals, Inc.,  announced the top-line results from its second fidaxomicin Phase 3 clinical study in patients with Clostridium difficile infection (CDI) at the 20th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria. 

As per the claim by the company, in the trial, fidaxomicin met the primary endpoint of non-inferiority in clinical cure compared to Vancocin®.  Importantly, fidaxomicin also had significantly lower recurrence rates compared to Vancocin (p = 0.002), and significantly higher global cure rates (defined as cure with no recurrence within four weeks of completing therapy) compared to Vancocin (p < 0.001).  Interestingly  the se robust results from this second fidaxomicin Phase 3 trial confirm the results from the first fidaxomicin Phase 3 trial.  Together these trials enrolled more than 1,100 subjects thus making them the two largest comparative studies ever conducted against Vancocin in CDI.

"Fidaxomicin offers potential advantages over existing therapies as a single agent that can provide a high cure rate and fewer recurrences for Clostridium difficile infection," said Dr. Crook, M.D., Consultant Microbiologist/Infectious Diseases and Professor of Infectious Diseases and Microbiology, Experimental Medicine Division, Nuffield Department of Clinical Medicine (NDM), University of Oxford"...  

Ref :  http://www.optimerpharma.com/news.asp?news_story=113&page_num=

Results of Phase 3 study of fidaxomicin...

We know that Fidaxomicin (also known as lipiarmycin, lipiarmycin A3, tiacumicin B, clostomicin B1, and OPT-80) is a new narrow spectrum macrocyclic antibiotic drug and being developed by Optimer Pharmaceuticals for treatment of Clostridium difficile infection. It works by inhibiting the bacterial enzyme RNA polymerase. It is active against gram positive bacteria especially clostridia.

Recently, Optimer Pharmaceuticals, Inc. (2. Nov, 2009) announced the presentation of new data from fidaxomicin's North American phase 3 study at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia, PA. The results are really encouraging and as per the claim by the company fidaxomicin is associated with faster resolution of diarrhea. In patients with more pronounced diarrhea (ie. not resolving in the first 24 hours of therapy), fidaxomicin was associated with a faster time to resolution of diarrhea than vancomycin (79 hrs vs. 105 hrs). The company claims that the faster time to resolution of diarrhea and improved outcomes for patients requiring concomitant antibiotics are important factors for physicians to consider when selecting a treatment for CDI more interesting factor is the significantly lower recurrence rate and higher global cure rate..

Ref : http://www.optimerpharma.com/news.asp?news_story=100&page_num=