Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate.
The FDA has approved Basilea’s Zevtera (ceftobiprole) for three different kinds of infections. The nods will help patients who have become resistant to the current stock of available antibiotics in the U.S., most of which have been on the market for decades.
Zevtera can be administered to adults with acute bacterial skin and skin structure infections (ABSSSI) and adults with staphylococcus aureus bacteremia (SAB), a bloodstream infection that can be fatal. It also can be used on patients 3 months and older to combat community-acquired bacterial pneumonia (CABP).
The SAB approval is particularly important, according to Vance Fowler Jr., M.D., professor in the departments of medicine and molecular genetics and microbiology at the Duke University School of Medicine, because it includes the ability to treat patients with methicillin-resistant staphylococcus aureus (MRSA).
“Complicated staphylococcus aureus infections have a high mortality rate and are associated with substantial morbidity,” Fowler said in a release. “We need more options for treating these infections, especially if MRSA is involved.”
With the nods, Basilea will gain 10 years of exclusivity in the U.S. for Zevtera as it was designated as a Qualified Infectious Disease Product under the Generate Antibiotics Incentives Now Act.
Basilea hopes by the “middle of this year” to sign up a partner to commercialize Zevtera in the U.S., a company spokesperson said, adding that it will be up to the collaborator to establish its price.
“We believe the U.S. provides the most important global opportunity for the brand,” Basilea CEO David Veitch said in a release.
With the nods, Basilea's share price increased by 11% on the Swiss Exchange.
Over the last 15 years, Basilea has gained approvals for Zevtera in more than 80 countries—including China, Canada, Brazil and most of Europe—to treat a variety of infections. But the U.S. has been a stubborn holdout.
In 2009, the FDA sent Basilea’s then-worldwide partner Johnson & Johnson a complete response letter (CRL) for its application to treat ABSSSI. The regulator critiqued spotty clinical trial work and requested the companies to conduct two more phase 3 studies. A year later, Basilea regained rights to Zevtera after J&J decided to move on from the drug.
In 2014, the FDA sent another CRL, rejecting Zevtera in CABP and requesting a new phase 3 trial.
The U.S. has helped Basilea fund additional trials through the Biomedical Advanced Research and Development Authority, which has provided the company $134 million in grants to address the shortfall of antibiotic options. According to the Centers for Disease Control and Prevention, more than 2.8 million people in the U.S. get antimicrobial-resistant infections each year, with 35,000 deaths recorded in 2019.
The trio of approvals were backed by separate trials that showed Zevtera provided comparable efficacy against comparator antibiotics. In SAB, Zevtera edged the comparator 70% to 69% in an overall measure of success. In ABSSSI, Zevtera outperformed the comparator 91% to 88%. In CABP, the comparator edged Zevtera 79% to 76%.
Zevtera is one of two products marketed by Basilea, with both on sales upswings. Cresemba, which was endorsed by the FDA in 2015, is for invasive fungal infections. Basilea recorded 150 million Swiss francs ($167 million) in revenue last year, which was up 23% from 2022. The company expects another major boost in growth this year, guiding to revenue of 180 million Swiss francs ($200 million).