EMA initiates ‘rolling review’ of remdesivir, potential COVID-19 treatment
The EMA’s human medicines committee has announced it has begun a rolling review of remdesivir for the treatment of COVID-19, to examine its safety and effectiveness.
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has announced it 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 means that the evaluation of remdesivir has begun – it does not imply that its benefits outweigh its risks. This kind of review is one of the regulatory tools used by the EMA to speed up the assessment of promising investigational medicines during a public health emergency, such as the ongoing COVID-19 pandemic.
Remdesivir is an antiviral medicine which is being investigated for the treatment of COVID-19. The drug is a viral RNA polymerase inhibitor and has shown broad in vitro activity against different RNA viruses, including SARS-CoV-2. Remdesivir was originally developed for the treatment of Ebola virus.
The drug is being developed by Gilead Sciences and is administered via infusion or drip into a vein.
Under normal circumstances, all data supporting a marketing authorisation application must be submitted at the start of the evaluation procedure. In the case of a rolling review, CHMP Rapporteurs are appointed whilst development is still ongoing and the EMA reviews data as it becomes available.
Several rolling review cycles can be carried out during the evaluation of one product as data continue to emerge, with each cycle lasting around two weeks depending on the amount of data to be assessed. Once the data package is complete, the developer submits a formal marketing authorisation application which is then processed under a shortened timetable.
While the overall review timeline for remdesivir cannot be anticipated at this moment, the EMA expects that this procedure will allow it to complete its assessment significantly earlier when compared with a regular evaluation procedure, while still ensuring a robust scientific opinion is reached.
The CHMP’s decision to start the rolling review of remdesivir is based on preliminary results from the ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with mild-to-moderate or severe COVID-19. However, the EMA has not yet evaluated the full study and emphasises that it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.
The CHMP will evaluate all data on remdesivir, including evidence from a recently published study from China and other clinical trials and conclude on the medicine’s benefits and risks as soon as possible.