The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk.
The review will facilitate the use of the therapy for emergency usage in countries in the EU.
Under this process, the ETF will analyse all available data, including findings from a trial in moderate-to-severe Covid-19 patients admitted to the hospital with increased ARDS and mortality risk.
According to the study findings, treatment with sabizabulin lowered the number of deaths in these subjects versus placebo.
This review will aid EU member states who may be considering permitting the usage of this therapy prior to a potential authorisation.
According to a press statement, ETF said: “The review is the first to be triggered under Article 18 of the new EU regulation that expanded the role of EMA during public health emergencies.”
The task force will carry out the review and provide recommendations to the EMA’s human medicines committee (CHMP), which will issue an opinion.
Furthermore, the CHMP notified the company that sabizabulin is eligible for filing an application seeking a centralised marketing authorisation.
Veru chairman, president and CEO Mitchell Steiner said: “By reducing deaths in hospitalised Covid-19 patients, sabizabulin has great potential to play a critical role in the battle against Covid-19 in the EU.
“This new emergency regulatory pathway may allow the availability of sabizabulin to EU member states prior to sabizabulin being approved by EMA.”
In June, the company filed an application seeking the US Food and Drug Administration (FDA) emergency use authorization (EUA) for a 9mg dose of oral sabizabulin for moderate-to-severe Covid-19 in hospitalised patients.