The US Food and Drug Administration (FDA) has accepted Basilea Pharmaceutica’s new drug application (NDA) for ceftobiprole, with the agency adding a Prescription Drug User Fee Act (PDUFA) goal date of 3 April 2024.
The Swiss pharma company stated it will commercialise the drug in the US through a partner, adding that it plans to enter a distributing deal prior to the PDUFA date.
If approved, the antibiotic would be available in the US for treating Staphylococcus aureus bacteremia (SAB) infections, including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Basilea has already marketed the antibiotic in several European countries as Zevtera and Mabelio for the treatment of hospital-acquired and community-acquired pneumonia, most often caused by the bacteria Streptococcus pneumoniae. The company is seeking to market ceftobiprole in the US bacterial infection market – predicted to be worth $4.1bn by 2024, according to GlobalData.
GlobalData is the parent company of Pharmaceutical Technology.
The FDA will now cross-examine clinical efficacy and safety data submitted by Basilea. The pharma company conducted three Phase III studies across the different conditions. The ERADICATE trial investigating ceftobiprole as a SAB treatment, TARGET trial for ABSSSI, and a study in CABP were subsidised by $112m worth of funding from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR), and the Biomedical Advanced Research and Development Authority (BARDA).
Basilea stated that the candidate would be eligible to receive ten years of market exclusivity if approved in the US, owing to ceftobiprole being designated as a Qualified Infectious Disease Product (QIDP) under the US Generate Antibiotics Incentives Now (GAIN) Act.
Ceftobiprole is an intravenously administered cephalosporin antibiotic that works against gram-positive bacteria, including methicillin-resistant strains, and gram-negative bacteria.
The company recently received $26.5m after its licence partner Pfizer triggered milestone payments in sales of the antifungal treatment Cresemba (isavuconazole) in Asia and China.
