EMA kicks off rolling review of Gilead’s remdesivir

Regulatory NewsRegulatory News | 01 May 2020 |  By 

Credit: NIAID-Rocky Mountain Laboratories

The European Medicines Agency (EMA) on Thursday said it has started a “rolling review” of Gilead’s investigational coronavirus disease (COVID-19) drug remdesivir after preliminary results from a US study found patients taking the drug recovered 31% faster than patients taking a placebo.
Preliminary results from the study, run by the National Institutes of Health (NIH), were announced Wednesday, the same day that less promising results from a Chinese study of the drug were published in The Lancet.
The NIH study also suggested a potential survival benefit associated with remdesivir, as patients taking the drug had a lower mortality rate than patients in the placebo arm (8% vs. 11.6%), though the result was not statistically significant.
In the Chinese study, which was halted early due to recruitment issues, researchers were unable to identify a statistically significant benefit for patients treated with remdesivir, though the study did point to a statistically insignificant “numerical reduction in time to clinical improvement,” that would need to be confirmed in a larger study.
The positive results from the NIH study triggered speculation that the US Food and Drug Administration (FDA) will issue an emergency use authorization (EUA) for remdesivir as it previously did for hydroxychloroquine and chloroquine. While FDA has not indicated if or when it would do so, FDA Commissioner Stephen Hahn told Bloomberg on Thursday that the agency is working at “lightning speed” to look over the data for remdesivir.
Under its rolling review procedure, EMA says that Committee for Medicinal Products for Human Use (CHMP) rapporteurs are assigned to the drug during its development to review data as it becomes available.
“While the overall review timeline for remdesivir cannot be anticipated at this moment, it is expected that this procedure will allow EMA to complete its assessment significantly earlier compared with a regular evaluation procedure,” EMA says, noting that several rolling review cycles may be carried out as data is generated.
EMA cautions that it is “too early to draw any conclusions regarding the benefit-risk balance of the medicine,” and notes that it has not yet evaluated the full study results.


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