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).
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By GlobalData
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.