Health Canada Evaluates Innovative COVID-19 Treatment
Valeo Pharma Inc. recently announced that Health Canada has accepted for review of Veru’s New Drug Submission (“NDS-CV”) for sabizabulin for treating COVID-19 patients.
Sabizabulin is a novel dual antiviral and anti-inflammatory agent being developed for treating hospitalized moderate to severe COVID-19 adult patients at high risk for acute respiratory distress syndrome (ARDS) and death.
“Health Canada’s filing acceptance of NDS-CV application for sabizabulin is the first important regulatory milestone in the drug approval process. Given the current number of hospitalized COVID-19 patients and the burden on provincial healthcare systems, there is a need to continually seek innovative treatment options,” said Steve Saviuk, CEO, in a press release on January 26, 2023.
“We will continue working closely with Veru to ensure, if approved, access to sabizabulin at the earliest possible time.”
In the final analysis of the Phase 3 clinical study conducted by Veru Inc., sabizabulin showed a 51.6% reduction in deaths compared to placebo in hospitalized adult patients with moderate to severe COVID-19 at high risk for ARDS. Sabizabulin also showed a significant decrease in days in an ICU, days on mechanical ventilation, and days in the hospital.
As of January 30, 2023, Health Canada has approved various COVID-19 therapies.