The US Food and Drug Administration (FDA) has approved Basilea Pharmaceutica’s intravenous cephalosporin antibiotic for three indications, providing an additional treatment option for a number of serious bacterial infections.
Zevtera (ceftobiprole medocaril sodium) has been authorised by the US regulator to treat Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) in adults, as well as community-acquired bacterial pneumonia (CABP) in adult and paediatric patients aged from three months to under 18 years.
The SAB approval includes patients with right-sided infective endocarditis, a complication associated with intravenous drug use, intracardiac devices and central venous catheters.
Antimicrobial resistance (AMR), particularly in Gram-negative bacteria, has been declared by the World Health Organization as one of the top ten threats to global health. It occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time, making infections harder to treat and increasing the risk of disease spread, severe illness and death.
Basilea outlined that Zevtera has “rapid bactericidal activity” against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains, and Gram-negative bacteria.
The FDA’s decision on the antibiotic was supported by positive results from three separate late-stage studies for each indication, with the SAB trial being the largest double-blind randomised registrational study conducted for a new antibiotic treatment in this patient population.
Dr Marc Engelhardt, chief medical officer of Basilea, described the approval as a “landmark” for Zevtera and reflective of its “broad clinical utility”.
He continued: “The indication in adult patients with SAB, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates,… addresses a real medical need, as current treatment options are limited.”
David Veitch, Basilea’s chief executive officer, said the FDA’s decision was a “key milestone towards bringing Zevtera to patients in the US”.
The approval comes shortly after Pfizer’s antibiotic combination, Emblaveo (aztreonam-avibactam), was recommended by the European Medicines Agency’s human medicines committee to treat infections caused by multidrug-resistant bacteria.
The Committee for Medicinal Products for Human Use recommended that Emblaveo be used in adults with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by aerobic Gram-negative bacteria where treatment options are limited.