The European Medicines Agency (EMA) has begun a rolling review of data on Gilead Sciences' remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.
EMA’s rolling review program enables the agency to assess data on a drug as they become available rather than waiting until the applicant has gathered all the required information before starting the evaluation procedure. The approach equips the EMA to complete the review of some of the data on a drug before the applicant formally files for approval, thereby setting the agency up to make a quick decision about whether to authorize a product for use in the EU.
At this stage, the EMA is yet to commit to a date by when it will make a decision on whether to approve the nucleotide analogue prodrug. However, the EMA expects the rolling review process to enable it to “complete its assessment significantly earlier” than if it followed its standard approach.
Based on how the rolling review process works under normal circumstances, the EMA may spend more time assessing remdesivir than the FDA, which is reportedly set to grant the drug Emergency Use Authorization imminently. There will be pressure on the EMA to further accelerate the process, though.
A single rolling review cycle at the EMA typically takes around two weeks, with the exact duration determined by the amount of data covered by the evaluation. The rolling review process can consist of several two-week cycles, meaning the EMA can spend a month or two assessing data before the applicant even files for approval. Once the EMA receives the filing, it processes the submission under “a shortened timetable.”
The EMA decided to begin the rolling review after a National Institutes of Health (NIH)-sponsored clinical trial linked remdesivir to a 31% reduction in the recovery times of patients with advanced COVID-19. While the trial failed to show a statistically significant effect on mortality, the positive top-line findings from a placebo-controlled clinical trial are expected to establish remdesivir as the first major tool in the armamentarium against COVID-19.
In a statement to disclose the start of the rolling review, the EMA said results from the NIH-sponsored trial “suggest a beneficial effect of remdesivir in the treatment of hospitalized patients with mild-to-moderate or severe COVID-19.” However, the EMA is yet to see the full data set and cautioned that “it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.”
The EMA will review data from the NIH-sponsored trial alongside results from other sources. The agency singled out a Chinese study—in which remdesivir performed no better than placebo—as a trial it would analyze as part of the rolling review. Other clinical trials will also inform the analysis, but the EMA only named the Chinese study.