EU body backs compassionate use of Gilead's remdesivir for COVID-19

The European Medicines Agency (EMA) on Friday said its Committee for Medicinal Products for Human Use (CHMP) recommended compassionate use of Gilead Sciences' investigational antiviral remdesivir to treat COVID-19. However, the agency cautioned that while remdesivir has been shown to be active against SARS-CoV-2 and other types of coronavirus in laboratory studies, there are "currently only limited data" on its use for COVID‑19 patients.

"Clinical trials remain the gold standard for the collection of robust data on the safety and effectiveness of investigational medicinal products, but the CHMP acknowledges the need for a harmonised approach to compassionate use in the EU to allow access to remdesivir for patients who are not eligible for inclusion in clinical trials," commented Harald Enzmann, chair of the CHMP. He said the group encourages Gilead to make remdesivir available "in a fair and transparent way to those member states wishing to take part in international clinical trials or treat patients in compassionate-use programmes."

According to the EMA, the recommendation comes after Estonia, Greece, the Netherlands and Romania requested an opinion from the CHMP on the conditions under which early access to remdesivir through compassionate use could be given to patients with COVID‑19.

Gilead recently decided to suspend its compassionate-use programme for remdesivir in the US due to "overwhelming demand." Instead, the company is now working on an expanded-access programme that would allow institutions to request the potential coronavirus treatment on behalf of multiple patients.

The experimental broad-spectrum antiviral, initially developed for use against Ebola, is being evaluated as a potential treatment for patients with COVID-19 in multiple trials around the world, including in the US, the UK and China.

For related analysis, see ViewPoints: Path cleared for chloroquine, while Gilead stays on the defensive.

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