New Antibiotic Approved for 3 Different Uses

On Wednesday, the FDA approved Zevtera to treat three types of infections, including Staphylococcus aureus in the bloodstream.

Manuel Balce Ceneta/AP photo

A new antibiotic has been approved by the U.S. Food and Drug Administration (FDA) to treat three different infections, giving health care providers a new tool in their toolkit.

Zevtera received approval on Wednesday for treating adults with Staphylococcus aureus (S. aureus) bloodstream infections, including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections; and adults and children with community-acquired bacterial pneumonia. The antibiotic is manufactured by Swiss pharmaceutical company Basilea Pharmaceutica.

“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections,” Dr. Peter Kim, director of the Division of Anti-Infectives in the FDA’s Center for Drug and Evaluation Research, said in a press release. “The FDA will continue our important work in this area as part of our efforts to protect the public health.”

Zevtera Outperforms Other Antibiotics in 2 of 3 Trials

Zevtera is an injectable ceftobiprole medocaril sodium. Ceftobiprole is an antibiotic that has been on the market for years and is used to treat complicated skin and soft tissue infections. Ceftobiprole medocaril is a newer-generation medication that can treat even more advanced or nuanced infections.

Researchers conducted a randomized, controlled, double-blind, multinational trial to test Zevtera’s efficacy against each of the infections listed above. In one study, researchers assigned 390 patients with S. aureus to receive either Zevtera or another antibiotic. Of those who received Zevtera, 69.8 percent saw symptoms improve and cleared the infection compared to 68.7 percent who received the other antibiotic.

“Complicated Staphylococcus aureus infections have a high mortality rate and are associated with substantial morbidity,“ Dr. Vance G. Fowler, the study’s lead investigator, said in a Basilea Pharmaceutica news release. ”We need more options for treating these infections, especially if MRSA (methicillin-resistant S. aureus) is involved.”

In a study on patients with acute bacterial skin and skin structure infections, 679 affected patients received either Zevtera or another combination of antibiotics. The study endpoints included whether the antibiotic would reduce skin lesions by at least 20 percent and sustain patient survival for at least 72 hours. The medication was also supposed to eliminate the need for further antibacterial treatment or unplanned surgery. Of those who received Zevtera, 91.3 percent achieved a timely clinical response compared to 88.1 percent who received the other medication.

Lastly, in the trial testing the antibiotic’s efficacy against community-acquired bacterial pneumonia, 638 patients received Zevtera or a different antibiotic. The main measure of efficacy was establishing a cure rate between seven and 14 days after treatment’s end. In this trial, the comparator outshone Zevtera by a few percentage points. Of those who received it, 76.4 percent reached the cure rate, compared to 79.3 percent on the comparator.

Common Side Effects

Like all medications, Zevtera has side effects, depending on the type of infection it’s treating. Common side effects include nausea, vomiting, diarrhea, headache, and abdominal pain. The FDA noted that Zevtera can increase mortality in ventilator-associated bacterial pneumonia patients (though this is an unapproved use) and cause hypersensitivity reactions, seizures, and other central nervous system reactions.

Basilea Pharmaceutica expects to make the antibiotic available to the U.S. market by midyear. The drug was granted 10-year market exclusivity.

“Whilst our initial goal was to announce a commercial partnership by the time Zevtera was approved in the US, in order to explore fully all potential partnering opportunities, we now expect to complete the process around mid-year,” Adesh Kaul, Basilea’s chief financial officer, said in the Basilea release. “In parallel, we are also taking preparatory steps to shorten the launch timelines, once we have entered into a commercialization partnership.”