FDA approves Basilea’s antibiotic Zevtera for three indications
Betsy Goodfellow | April 4, 2024 | News story | Medical Communications | Basilea Pharmaceutica, FDA, Infections and infestations, Zevtera, antibiotic
Basilea Pharmaceutica has announced that the US Food and Drug Administration (FDA) has approved Zevtera (ceftobiprole medocaril sodium for injection), as a new antibiotic for three indications.
The drug is approved for the treatment of adult patients with Staphylococcus aureus bloodstream infections (SAB), including patients who have right-sided infective endocarditis, adult patients with acute bacterial skin and skin structure infections (ABSSSI), and for adult and paediatric patients (from three months to 18 years of age) with community-acquired bacterial pneumonia (CABP).
The approval follows a New Drug Application (NDA), which was supported by clinical efficacy and safety data from the company’s phase 3 studies ERADICATE (SAB) and TARGET (ABSSSI), as well as a phase 3 trial in CABP.
Dr Marc Engelhardt, chief medical officer of Basilea, commented: “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.”
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 commercialisation partnership.”
Betsy Goodfellow
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