Johnson & Johnson submits NDA to FDA for skin-infection antibiotic ceftobiprole

Raritan, N.J. - Johnson & Johnson Pharmaceutical Research & Development, based here, has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for ceftobiprole, PRNewswire reports.

Ceftobiprole is an investigational antibiotic for the treatment of skin and skin-structure infections, such as diabetic foot infections, in adults. The FDA has granted the drug “fast-track” status.

Clinical trials showed ceftobiprole to have high cure rates in patients with complicated skin infections, including methicillin-resistant Staphylococcus aureus (MRSA), the potentially lethal “super bug,” which is the predominant bacteria associated with skin infections.

According to the Centers for Disease Control and Prevention, some 25 percent to 30 percent of the U.S. population carries some form of Staphylococcus aureus, and many of those individuals carry MRSA, which is highly resistant to most available antibiotics. Reports of outbreaks of MRSA have been increasing, thus creating a growing public-health concern.

The phase 3 data supporting the NDA showed that ceftobiprole demonstrated broad-spectrum coverage in serious infections including diabetic foot infections, but unlike currently available cephalosporins - the class of antibacterial agents to which ceftobiprole belongs - ceftibiprole exhibited activity against MRSA.

In the trials, ceftobiprole was well-tolerated, with common adverse events that included nausea, taste disturbance, diarrhea and vomiting.