In its CRL, the agency confirmed that patients with Coma Grade I/II observed a numerically higher rate of transplant-free survival, but also noted that there was not sufficient evidence of efficacy for the proposed indication of increasing survival in all patients with acute liver failure.
The filing of sNDA for the new indication was based in part on data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that acute liver failure patients treated with Acetadote have an improved chance of survival without a transplant.
Cumberland Pharma CEO AJ Kazimi said that they appreciate the FDA’s efforts to review this application, and they share the agency’s commitment to providing pharmaceutical products that meet the highest standards of safety and efficacy for patient groups who will truly benefit.
" We plan to request a meeting with the FDA to resolve the outstanding issues related to this application and look forward to working closely with the agency to gain clarity on the pathway to approval for this important indication," Kazimi said.