FDA acceptance Basilea’s New Drug Application for antibiotic ceftobiproleOctober 2, 2023
A commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, Basilea Pharmaceutica, said Monday that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the antibiotic ceftobiprole.
With this NDA, Basilea said it is seeking approval for treating patients in three indications: Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The FDA has set April 03, 2024, as the Prescription Drug User Fee Act (PDUFA) goal date, Basilea said.
Furthermore, the PDUFA goal date indicates the date for the FDA to complete its review of the NDA, which is supported by clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB), TARGET (ABSSSI), and a phase 3 study in CABP. The ERADICATE study was the largest double-blind randomized registrational study conducted for a new antibiotic treatment in SAB, Basilea said.
Dr. Marc Engelhardt, Chief Medical Officer, is pleased with the FDA’s acceptance of the company’s New Drug Application, which is seen as an important step towards bringing ceftobiprole to patients with severe bacterial infections in the US. Dr. Engelhardt commented that there is a high medical need for new antibiotic treatment options, especially in complicated SAB. “We look forward to working closely with the FDA throughout their review process,” he said.
Ceftobiprole has been designated a Qualified Infectious Disease Product (QIDP) under the US Generate Antibiotics Incentives Now (GAIN) Act; hence, subject to approval, ceftobiprole would be eligible to receive ten years of market exclusivity in the US from the date of approval. Basilea is planning to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the PDUFA goal date.