FDA approves breakthrough therapy for pneumonia

Innoviva landed a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with US Food and Drug Administration FDA approval for use in patients 18 years of age or older. Intravenous therapy has become the first pathogen-targeted therapy approved for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex (ABC).

Xacduro was originally developed by Entasis Therapeutics. Innoviva acquired all of the outstanding shares of Entasis in a $113 million deal in May 2022 for $2.20 per share in cash, following a 2020 deal that left the largest pharmaceutical company 60% of the outstanding shares of the latter company.

The FDA approval stems from the results of Entasis’ Phase III attack trial (NCT03894046). Study data demonstrated that Xacduro demonstrated statistical non-inferiority to the antibiotic colistin for the primary endpoint of 28-day all-cause mortality in patients with drug-resistant ABC infections. carbapenems. At an April 2023 advisory committee meeting to discuss this therapy, all 12 panelists voted in favor of approving Xacduro.

ABC consists of four species of bacteria from the Acinetobacter family. In 2017, the World Health Organization reported that Acinetobacter species is the bacterial pathogen most at risk to human health. The agency explained that this species poses a particular risk of multidrug resistance and can cause serious infections such as pneumonia. The bacterial species is commonly spread in healthcare settings through direct contact between hands and contaminated surfaces, which poses an additional risk to patients.

Massachusetts-based Enstasis currently has three other precision antibiotic therapies in its clinical portfolio. These range from therapies used to treat urinary tract infections to antibiotics for uncomplicated gonorrhea.

Director of the FDA’s Center for Drug Evaluation and Research (CDER) Anti-Infectives Division, Dr. Peter Kim, said, “The FDA is dedicated to supporting the development of safe treatment options. and effective for infections caused by to treat bacteria like ABC.

In a press release, Innoviva’s Chief Medical Officer, Dr. David Altarac, said, “The FDA approval of XACDURO marks an important milestone in our goal to provide differentiated therapies to critically ill patients who have limited treatment options.

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