The European Medicines Agency’s (EMA) Emergency Task Force (ETF) announced on Wednesday 27 July that it had undertaken an analysis of data on sabizabulin, an oral treatment originally developed as an anti-cancer therapy by Veru Inc. to assess the use of this medicine in the treatment of Covid-19.
Veru has not yet formally applied for market authorisation and this is not an ongoing evaluation.
This is the first review conducted by the ETF under Article 18 (3 and 4) of Regulation EU/2022/123 which strengthens the mandate of the EMA. This legal basis allows the ETF, after a public health emergency has been declared, to review existing data on medicines that may be used in the context of that emergency. This type of review may be requested in the context of a public health emergency by one or more Member States or by the European Commission.
Following this review, the ETF may make recommendations to the EMA’s Committee for Medicinal Products for Human Use (CHMP), with a view to drawing up an opinion for the compassionate use of certain types of medicines or for the use and distribution of medicines not yet authorised in the European Union.
In this case, Germany has requested the use of sabizabulin to treat Covid-19, although the medicine is not yet authorised for this use in the EU. (Original version in French by Émilie Vanderhulst)