Florida-based Veru Inc. today announced that the European Medicines Agency's (EMA) Emergency Task Force (ETF) had informed the Company that it has initiated the review of sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS).
Sabizabulin is an oral, novel microtubule disruptor with dual antiviral and anti-inflammatory activity in preclinical models.
On July 27, 2022, the Company stated, "The review will look at all available data, including data from a study involving hospitalized patients with moderate-to-severe COVID-19 who are at high risk of ARDS and death.
"The results of this phase 3 study would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo."
The NEJM published this study on July 6, 2022: Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis.
Sabizabulin treatment resulted in a 24.9% absolute reduction in deaths compared with placebo in hospitalized patients with moderate to severe Covid-19 at high risk for ARDS and death, with a lower incidence of adverse and serious adverse events compared with placebo.
Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru, commented in a press release, "This new emergency regulatory pathway may allow the availability of sabizabulin to EU member states before sabizabulin is approved by EMA."
"Separately, we were also informed yesterday that the sabizabulin product is eligible for submission (Article 18) of an application for a centralized marketing authorization."
"COVID-19 infections are sharply rising in Europe. Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 at risk for ARDS remains unacceptably high with the current standard of c"re," added Dr. Stein"r.
"By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 in the"EU."
Additional COVID-19 treatment news is posted at CoronavirusToday.com/Antivirals.
Note: Ths Company's announcement was manually curated for mobile readers.