The European Medicines Agency (EMA) has received an application for conditional marketing authorisation (CMA) of remdesivir for the treatment of COVID-19 and has formally started its evaluation under a reduced timeline. An opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation.
Some data have already been assessed as part of a rolling review, which started on 30 April and was concluded on 15 May.
During the rolling review, the EMA’s Committee for Medicinal Products for Human Use (CHMP) assessed data on quality and manufacturing, preliminary data from several clinical studies and supporting data from compassionate use programmes.
In parallel, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) completed an initial assessment of the preliminary risk management plan (RMP) proposed by the company. Furthermore, the EMA’s committee for medicines for children (PDCO) issued its opinion on the company’s paediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children.
If the CHMP concludes that the benefits of remdesivir outweigh its risks, the agency will liaise with the European Commission to fast-tracking marketing authorisation which will be valid in all EU and EEA Member States.