The European Medicines Agency’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID-19 can be treated.
Remdesivir is a viral RNA polymerase inhibitor, which has shown broad in vitro activity against different RNA viruses and was originally developed for the treatment of Ebola virus.
These updated recommendations are made in light of the preliminary results from the National Institute of Allergy and Infectious Diseases - Adaptive COVID-19 Treatment Trial (NIAID-ACTT), which suggest a beneficial effect of remdesivir in the treatment of severe COVID-19.
Treatment with remdesivir is now recommended for hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or extracorporeal membrane oxygenation (ECMO).
A treatment duration of five days is suggested for those not requiring mechanical ventilation. This may be continued for an additional five days if clinical improvement is not achieved. This shortened treatment duration, from 10 days, means that more patients may be able to receive the medicine, currently in high demand globally.
The compassionate use recommendations will enable patients to access remdesivir while the EMA continues to evaluate the benefits and risks data.