EMA Commences Rolling Review of Remdesivir Data as COVID-19 Treatment

12 May 2020

BioPharm International

A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

The start of CHMP’s rolling review, which was announced in an April 30, 2020 press release, has been based on preliminary data from the Adaptive COVID-19 Treatment Trial (ACTT) that suggest a beneficial effect of remdesivir in patients hospitalized with mild-to-moderate or severe COVID-19. However, the agency body has not completed a full evaluation of the study and has stated that it is too premature to conclude on the potential benefit-risk balance of the medicine. 

Rolling reviews are optional tools that can be employed by the regulatory agency to speed up the assessment of a potentially promising investigational medicine at the time of a public health emergency. Contrary to a normal marketing authorization application, where all data must be submitted at the outset of the process, during a rolling review, CHMP Rapporteurs are appointed while the development is ongoing and data are reviewed by the agency as they become available.

All data on remdesivir, including from recently published studies, such as one from China and other clinical trials, will be reviewed by CHMP. The aim is for the agency to reach a conclusion on the benefits of the medicine as quickly as possible.




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