Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)
Innoviva, Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the new drug application (NDA) for SUL-DUR, an investigational drug for the treatment of infections caused by Acinetobacter baumannii-calcoaceticus complex (ABC), including multi-drug resistant and carbapenem-resistant strains. The Agency is currently planning to hold an advisory committee meeting to discuss this application. The target PDUFA date (or action date) is May 29, 2023.
The NDA submission is based on results from the landmark Phase 3 ATTACK trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by ABC. In the trial, SUL-DUR demonstrated statistical non-inferiority versus colistin for the primary end point of 28-day all-cause mortality in patients with carbapenem-resistant ABC infections and a significant difference in clinical cure rates. SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.
“Carbapenem-resistant and multidrug-resistant Acinetobacter infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options. The acceptance of our NDA brings us one step closer to potentially delivering SUL-DUR to patients in this area of high unmet medical need,” said David Altarac, MD, Chief Medical Officer of Entasis Therapeutics, a wholly-owned subsidiary of Innoviva. “Our focused and dedicated team looks forward to continuing to work with the FDA throughout the priority review process.”
About the Phase 3 ATTACK Trial
The ATTACK trial was conducted to evaluate the efficacy and safety of SUL-DUR versus colistin, both in combination with imipenem/cilastatin as background therapy, for patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections, including carbapenem-resistant and multidrug-resistant strains. The trial consisted of two parts: Part A was a randomized, blinded arm (SUL-DUR versus colistin; non-inferiority margin 20%) in ABC hospital-acquired pneumonia, ventilator-associated bacterial pneumonia, ventilated pneumonia, or bacteremia; Part B was an open label arm (SUL-DUR only) that enrolled patients with ABC infections who did not tolerate colistin/polymyxin B or whose pathogens were resistant to colistin/polymyxin B. The primary efficacy endpoint for the trial was 28-day all-cause mortality. The primary safety objective of the trial was incidence of nephrotoxicity (as measured by the modified RIFLE Criteria).