EMA reviewing data on COVID-19 savizabrin

The EMA Emergency Task Force (ETF) has begun reviewing data on the use of savizabrin for the treatment of COVID-19.

This review reviews all available data, including data from studies of inpatients with moderate to severe COVID-19 who are at high risk of acute respiratory distress syndrome and death.[1] The results of this study show that savizabrin treatment can reduce the number of deaths in these patients compared to placebo (dummy treatment).

Developer Veru has not yet filed a marketing approval or rolling review with the EMA, but the review (based on data from the company) may consider permitting the use of the drug prior to approval. We support some EU member states.

This review is the first to be triggered under Article 18 of the new EU Regulation (Reg 2022/123). Expanding the role of EMA During a public health emergency. The ETF will carry out this review and send recommendations to the Agency’s Committee for Medicinal Products for Human Use (CHMP), which publishes the agency’s views.

EMA will notify you of the results of the review when the review is complete.

More about medicine

Savizabrin works by destroying the microtubules that form part of the cell’s internal skeleton. These microtubules play a role in helping SARS-CoV-2, the virus that causes COVID-19, enter and leave cells. By binding to parts of microtubules, savizabrin is expected to disrupt the viral life cycle and limit its replication and spread.

Savizabrin is also expected to suppress some inflammatory reactions that occur after SARS-CoV-2 infection. This includes reactions that can lead to acute respiratory distress syndrome and death.

Step details

The review of Savizabrin was initiated on July 27, 2022 under Article 18. Rule 2022/123, At the request of Germany. The EMA Emergency Task Force (ETF) conducts reviews in accordance with Section 18 (3), sends recommendations to the EMA’s Committee for Medicinal Products for Human Use (CHMP), and publishes the views of the authorities.

EU Member States can then consider their views if they permit the use of the drug prior to approval.

The Savizabrin review will be the first review conducted under Section 18 (3 and 4) of Rule 2022/123. For public health emergencies, such Article 18 reviews replace those previously conducted. Rule 726/2004, Article 5 (3)..