EMA backs expanding remdesivir compassionate use

The European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) has recommended expanding the compassionate use of Gilead Sciences’ (Nasdaq: GILD) remdesivir so that more patients with severe COVID‑19 can be treated.

In addition to patients undergoing invasive mechanical ventilation, the recommendations now cover the treatment of hospitalized patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation).

The updated recommendations are based on preliminary results from the NIAID-ACTT research data, which suggest a beneficial effect of remdesivir in the treatment of hospitalized patients with severe COVID-19, and was used along with Gilead’s own trial data to gain emergency use approval for remdesivir in the USA, which in turn led to the drug being granted ‘exceptional’ use, under the trade name Veklury, by the Japanese regulator.