EU regulator promises speedy review of potential COVID-19 drug remdesivir
(Reuters) – The European health regulator has vowed to conduct a speedy review of Gilead Sciences’ potential COVID-19 drug, remdesivir, but said it has not yet received an application from the US drugmaker.
The European Medicines Agency (EMA) said on Friday its human medicines committee’s (CHMP) timeline to assess the drug would be “reduced to the absolute minimum,”.
The announcement comes two weeks after the EMA head told the European Parliament it may give an initial green light for sale of remdesivir as a COVID-19 treatment, fast-tracking the drug to market amid tight global competition for resources.
There are currently no approved medication or vaccine for the highly-contagious and sometimes fatal illness.
The United States, the world’s biggest pharmaceutical market, earlier this month granted emergency use authorization for remdesivir in COVID-19, clearing the way for broader use of the drug, but is yet to approve it.
The EMA has been reviewing the drug periodically and suggested a beneficial effect in treating hospitalised patients with mild-to-moderate or severe COVID-19.
While final approvals are up to the European Commission, it generally takes and endorses CHMP recommendations.