The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a rolling review of the investigational antiviral medicine for the treatment of COVID-19 patients called remdesivir, a viral RNA polymerase inhibitor previously indicated for use against Ebola.
A rolling review is one of the regulatory tools available to the EMA to accelerate the assessment of a promising investigational medicine during a public health emergency. Normally, all data supporting a marketing authorisation application (MAA) must be submitted at the start of the evaluation procedure. In a rolling review, CHMP “Rapporteurs” are appointed whilst drug development is still progressing and EMA reviews data as it becomes available. Once the data package is complete, the applicant submits a formal MAA which is then processed through a shortened timeframe.
The CHMP’s decision to start the rolling review of remdesivir is based on preliminary results from an American Adaptive COVID-19 Treatment Trial (ACTT) run by the National Institutes of Health (NIH) , which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with mild-to-moderate or severe COVID-19. The study found that patients taking the drug recovered 31% faster than patients taking a placebo. However, EMA has not yet evaluated the full study and it is too early to make conclusions on the benefit-risk balance of the medicine.
Previously, the CHMP have given recommendations on the compassionate use of remdesivir for COVID-19. Compassionate use programmes are set up by individual EU Member States (MS), with the intention of giving patients with a life-threatening, long-lasting or seriously disabling disease and no available treatment options, access to treatments that are still under development and that have not yet received a marketing authorisation.
Based on the results of the NIH ACTT study, the US Food and Drug Administration (FDA) have issued an emergency use authorisation (EUA) allowing the use of remdesivir to treat hospitalised patients with severe cases of COVID-19. The EUA allows remdesivir to be used to treat adults and children with suspected or laboratory confirmed cases of COVID-19 with severe disease who have low levels of oxygen saturation (Sp02 ≤ 94%) or who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO). However, FDA states that “there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19.”
Results from other studies of remdesivir have been mixed. In a Chinese study published at the same time, researchers were unable to identify a statistically significant clinical benefit of the antiviral drug, although the study was stopped early due to recruitment issues. Another unpublished US study comparing 5- and 10-day dosing regimens found patients in both arms of the study had similar improvement in clinical outcomes.
Only time and efficient data collection will tell whether this drug is clinically effective and warrants further global regulatory approval. To find out more about the EMA’s rolling review, click here.