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Basilea seeks US FDA approval for antibiotic ceftobiprole to treat SAB, ABSSSI, and CABP

Basilea Pharmaceutica Ltd, Allschwil, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA). With this NDA, Basilea is seeking approval of its antibiotic ceftobiprole 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).

Dr. Marc Engelhardt, chief medical officer, said: “Staphylococcus aureus bacteremia is a common bloodstream infection with an estimated 120,000 cases in the US per year and is associated with substantial morbidity and mortality. Our completed phase 3 program demonstrates the efficacy of ceftobiprole in this complicated infection. The additional successfully completed phase 3 studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole. Based on its potent antibacterial activity ceftobiprole could become a valuable new treatment option for severe bacterial infections in the US, especially when methicillin-resistant Staphylococcus aureus bacteria, MRSA, are of concern.”

The NDA submission includes 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.

Ceftobiprole has been designated a Qualified Infectious Disease Product (QIDP) under the US Generate Antibiotics Incentives Now (GAIN) Act, which provides for a Priority Review within eight months from submission. Provided that the NDA submission is accepted, Basilea expects a decision by the FDA on the NDA in the second quarter of 2024. Basilea plans to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the FDA’s decision on the NDA.

Basilea’s ceftobiprole phase 3 programme, 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 per cent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole, is a cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria. The brand is currently approved and marketed as Zevtera and Mabelio in several countries in Europe and beyond for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. Ceftobiprole is currently not approved and partnered in the US.

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. The company committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections.