Rolling submission at EMA for remdesivir to treat coronavirus disease.- Gilead Sciences

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19). The start of the rolling review only means that the evaluation of remdesivir has started and does not imply that its benefits outweigh its risks.

Rolling review is one of the regulatory tools available to the Agency to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic.In the case of a rolling review, CHMP Rapporteurs are appointed whilst development is still ongoing and the Agency reviews data as they become available.

While the overall review timeline for remdesivir cannot be anticipated at this moment, it is expected that this procedure will allow EMA to complete its assessment significantly earlier compared with a regular evaluation procedure, while still ensuring a robust scientific opinion is reached.

Although remdesivir is not yet authorised in the European Union, it is available to patients through clinical trials and so-called ‘compassionate use’ programmes through which patients can get access to unauthorised medicines in emergency situations..