NEWS | BEAM Alliance


Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole

  • Seeking approval for Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP)
  • Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024

Allschwil, Switzerland, October 02, 2023

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the antibiotic ceftobiprole, which was submitted to the FDA on August 3rd this year. With this NDA, Basilea 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.

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.

Dr. Marc Engelhardt, Chief Medical Officer, said: “We are pleased with the FDA’s acceptance of our New Drug Application, which is another important step towards bringing ceftobiprole to patients with severe bacterial infections in the US, as 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.”

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.

Basilea’s ceftobiprole phase 3 program is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

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