EMA grants conditional approval for remdesivir in the EU to treat COVID-19

22 July 2020. Related: COVID-19: investigational drugs, COVID-19.

Simon Collins, HIV i-Base

On 3 July 2020, the European Medicines Agency (EMA) announced conditional approval in the EU for remdesivir as a treatment for COVID-19. This was only a week after the CHMP had recommended approval. [1, 2]

Conditional approval will allow immediate access to remdesivir and is valid for one year, but also requires supplementary efficacy and safety results to be submitted by August and December 2020. 

Although the submission for approval was only made on 5 June, the EMA has been evaluating accumulating results from remdesivir studies since late April.

The indication is for adults and children (>12 years old and weighing >40 kg) with pneumonia who require supplemental oxygen.

Approval is largely based on results from the US NIH randomised placebo-controlled ACTT study that reported an overall average 5-day shorter recovery time (approximately 9 vs 15 days) with remdesivir (dosed for 10 days) compared to placebo. [3]

However, differences were reported depending on severity of COVID-19 at baseline. No differences were reported for participants with mild-moderate disease (at 5 days in both active and placebo arms) or in people who started mechanical ventilation while already taking remdesivir. The difference was driven by the 90% of participants with severe disease (12 vs 18 days).

Remdesivir is manufactured by Gilead Sciences with the trade name Veklury. Other research studies are ongoing.

The dose is not referred to in the press release (specifically whether this should be up to five or ten days).

References

1. Gilead press release. European Commission grants conditional marketing authorization for Gilead’s Veklury (remdesivir) for the treatment of COVID-19. (3 July 2020).
   https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/european-commission-grants-conditional-marketing-authorization-for-gileads-veklury-remdesivir-for-the-treatment-of-covid19
2. EMA press release. First COVID-19 treatment recommended for EU authorization. (25 June 2020).
   https://www.ema.europa.eu/en/news/first-covid-19-treatment-recommended-eu-authorisation
3. Remdesivir improves recovery time in early COVID-19 infection: first definitive results of benefit. HTB (supple 4). (1 June 2020).
   https://i-base.info/htb/37976

This report was first published on 2 July 2020.