- The Food and Drug Administration on Tuesday approved a new drug for hospital-acquired pneumonia caused by a difficult-to-treat type of bacteria.
- The drug, which will be sold as Xacduro by Innoviva Specialty Therapeutics, targets susceptible strains of Acinetobacter baumannii-calcoaceticus complex, which can cause infections throughout the body and can become resistant to existing treatments.
- The World Health Organization has named Acinetobacter species as a major human health threat, highlighting the need for more antibiotics. But developing new treatments has been challenging for drugmakers, which face difficulties in research as well as in successfully commercializing any medicines they create.
Acinetobacter baumannii are a common cause of pneumonia in hospitals, and infections can be life-threatening.
Innoviva’s treatment consists of a drug, sulbactam, that’s similarly structured as the antibiotic penicillin, along with another compound, durlobactam, that helps protect it from degradation. It’s taken intravenously and is cleared for use in people aged 18 and older.
The FDA based its approval on results from a Phase 3 trial that enrolled 207 hospitalized participants who either received Xacduro or another, existing antibiotic called colistin. Trial data showed treatment with Xacduro was no worse than the comparison treatment when measuring death from any cause 28 days after treatment for a confirmed infection of drug-resistant Acinetobacter baumannii.
Xacduro was associated with abnormal liver function tests, and its labeling contains warnings for hypersensitivity reactions and Clostridioides difficile-associated diarrhea
“Xacduro is the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by acinetobacter,” David Altarac, chief medical officer of Innoviva Specialty Therapeutics, said in a statement.
The drug was submitted to the FDA by Entasis Therapeutics, which was acquired by Innoviva last year and recently merged with another company Innoviva bought, La Jolla Pharmaceutical, to create Innoviva Specialty Therapeutics.
Through La Jolla, Innoviva Specialty Therapeutics also markets two other products, including an antibiotic known as Xerava for intra-abdominal infections. Innoviva said it expects to make Xacduro available later this year.
While the pipeline of new antibiotics remains anemic, other drugmakers like GSK are advancing treatments. The British pharmaceutical company has developed an oral antibiotic for uncomplicated urinary tract infections, and is planning to soon submit for FDA approval.