EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19.

The review will look at all available data, including data from a study involving hospitalised patients with moderate-to-severe COVID-19 who are at high risk of acute respiratory distress syndrome and death.

The results of this study indicate that sabizabulin treatment could reduce the number of deaths in these patients compared with placebo (a dummy treatment).

Although the developer, Veru, has not yet applied to EMA for a marketing authorisation or a rolling review, the review (based on data from the company) will assist EU Member States who may consider allowing use of the medicine before a possible authorisation.

The review is the first to be triggered under Article 18 of the new EU regulation (Reg 2022/123) that expanded the role of EMA during public health emergencies. The ETF will conduct this review and send recommendations to the Agency’s human medicines committee (CHMP), which will issue the Agency’s opinion.

EMA will communicate on the outcome of the review when it concludes.

EMA press release in "Related documents"