EMA starts remdesivir rolling review

The European Medicines Agency (EMA) has announced that it has started a rolling review of data on the use of the drug of the moment – Gilead Sciences’ (Nasdaq: GILD) remdesivir – for the treatment of coronavirus disease (COVID-19).

Using the rolling review process 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, so is highly appropriate for the ongoing pandemic.

Under normal circumstances, all data supporting a marketing authorization application must be submitted at the start of the evaluation procedure. In the case of a rolling review, rapporteurs from the EMA’s Committee for Medicinal Products for Human Use are appointed while development is still ongoing, and the agency reviews data as they become available.