EMA recommends remdesivir to treat COVID-19, authorization expected next week

Regulatory NewsRegulatory News | 25 June 2020 |  By 

Following a rolling review that kicked off in late April, the European Medicines Agency (EMA) on Thursday recommended conditionally authorizing Gilead Sciences’ (Veklury) remdesivir to treat patients ages 12 and older with severe coronavirus disease (COVID-19) requiring supplemental oxygen.
EMA says it expects the European Commission to sign off on the conditional marketing authorization for remdesivir next week using a fast-track process, which will allow the drug to be marketed across the EU.
“From 30 April 2020, the [Committee for Medicinal Products for Human Use] CHMP began assessing the data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, well in advance of the submission of the marketing authorization application on 5 June,” EMA says. The decision to recommend the drug was largely based on the results of a US study sponsored by the National Institutes of Health that found hospitalized patients recovered 4 days sooner than patients who received a placebo.
As part of the conditional marketing authorization, EMA says Gilead will have to submit final study reports for remdesivir by December 2020 and additional data on quality and final mortality data by August 2020.
The recommendation to conditionally authorize remdesivir follows the US Food and Drug Administration’s decision to authorize the drug for emergency use last month. (RELATED: FDA authorizes Gilead’s remdesivir for emergency use, Regulatory Focus 1 May 2020). The drug is currently authorized for emergency use in India, Singapore and South Korea and fully approved in Japan.
Gilead is also working to develop an inhaled formulation of the drug that would be easier to administer than its current intravenous form.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy