Merck's antibacterial med Dificid Gets FDA nod in Pediatric Indication

Merck & Co., Inc announced that the FDA has granted approval to its new drug application ("NDA") and a supplemental NDA (sNDA) for its antibacterial medicine Dificid (fidaxomicin). The NDA sought approval for an oral suspension formulation of Dificid, which is presently available in tablet form. The sNDA aimed at approval for Dificid tablets to treat Clostridium difficile-associated diarrhea ("CDAD") in children aged six months and above.

The approval for Dificid tablets and oral suspension was based on data from the phase III SUNSHINE study.

The SUNSHINE study evaluated Dificid in patients aged six months to less than 18 years in comparison to antibiotic, vancomycin. Data from the SUNSHINE study showed that while CDAD clinical response was similar for both drugs, sustained clinical response was higher for patients receiving Dificid.

The company stated that there are almost 500,000 infections caused by Clostridioides difficile every year in the United States. This bacterial infection is also estimated to cause approximately 29,000 deaths within 30 days of initial diagnosis. These numbers suggest that the drug has significant potential in the targeted indication.

Merck has many pipeline candidates in advanced stages of development, targeting multiple disease areas such as oncology, cardiovascular diseases, diabetes, infectious diseases, neurosciences, respiratory and immunology diseases, and vaccines.

Some of the important pipeline candidates include selumetinib, which is under review in the United States for pediatric neurofibromatosis type 1; MK-6482 in mid-stage study for renal cell carcinoma; V114 (15-valent pneumococcal conjugate vaccine) and chronic heart failure candidate, vericiguat in late-stage studies.