Basilea Pharma Receives US FDA Approval of Antibiotic Zevtera

Basilea Pharma Receives US FDA Approval of Antibiotic Zevtera

By, Admin 5 April 2024

Basilea Pharma receives US FDA approval of antibiotic Zevtera for three indications

Overview

Basilea Pharmaceutica Ltd, Allschwil, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced that the US Food and Drug Administration (FDA) approved Zevtera (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and paediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

Words from CEO: Basilea

David Veitch, chief executive officer of Basilea, said: “We are excited with the US approval of Zevtera. The positive decision by the FDA is a key milestone towards bringing Zevtera to patients in the US. Zevtera has 10 years of market exclusivity from the date of approval and we believe the US provides the most important global commercial opportunity for the brand.”

Words from CMO: Basilea

Dr. Marc Engelhardt, chief medical officer of Basilea, stated: “We are very pleased that the FDA approved Zevtera for all three indications that were submitted with the NDA, including a paediatric labelling. This approval is a landmark for ceftobiprole and reflects its broad clinical utility. The indication in adult patients with Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates, MSSA and MRSA, addresses a real medical need, as current treatment options are limited.”

New Drug Application

  • The New Drug Application (NDA) was supported by clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB)1 and TARGET (ABSSSI),2 and a phase 3 study in CABP.
  • 3 The ERADICATE study was the largest double-blind randomized registrational study conducted for a new antibiotic treatment in SAB.

Words from Experts

  • Vance G. Fowler, Jr., M.D., Professor in the Departments of Medicine and Molecular Genetics & Microbiology at the Duke University School of Medicine and academic lead investigator of the ERADICATE study, commented: “Complicated Staphylococcus aureus infections have a high mortality rate and are associated with substantial morbidity. We need more options for treating these infections, especially if MRSA is involved.”
  • Thomas Holland, M.D., Associate Professor in the Department of Medicine at the Duke University School of Medicine and chair of the data review committee of the ERADICATE study, added: “There is a high medical need in Staphylococcus aureus bacteremia, therefore, the first approval of a therapy for this indication in over 15 years is highly welcome.”

From Basilea

Adesh Kaul, chief financial officer of Basilea, added: “As we were moving towards completion of the regulatory review, especially with increasing visibility on the expected label, the external interest for commercial partnering increased. Whilst our initial goal was to have announced a commercial partnership by the time of approval of Zevtera in the US, in order to explore fully all potential partnering opportunities, we now expect to complete the process around mid-year. In parallel, we are also taking preparatory steps to shorten the launch timelines, once we have entered into a commercialization partnership.”

Programme Funding

Basilea’s phase 3 programme for ceftobiprole 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. Through this partnership, 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.

About Ceftobiprole

  • Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation 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. 
  • In several countries in Europe and beyond, the brand is currently approved and marketed as Zevtera and Mabelio 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. In the United States, Zevtera is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and paediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

Staphylococcus Aureus Bacteremia

  • Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. 
  • Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. 
  • With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB.

ABSSSI

  • Acute bacterial skin and skin structure infections (ABSSSI) are common infections in the healthcare setting. 
  • Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved.

CABP

  • Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. 
  • It is the leading cause of infectious disease-related death in the US.

About Basilea

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 and fungal infections.

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