Remdesivir could be granted conditional marketing authorisation ‘in the coming days’, says EMA

The investigational antiviral medicine, remdesivir, may be granted a conditional marketing authorisation as a treatment for COVID-19 “in the coming days”, the head of the European Medicines Agency (EMA) has said.

On 30 April 2020, the EMA’s Committee for Medicinal Products for Human Use (CHMP) started a rolling review of data on the use of remdesivir for treating COVID-19.

“The first cycle of this rolling review has now been concluded,” said a spokesperson for the EMA.

“The CHMP has requested some further data and agreed that the next step would be for the company to submit this data together with an application for a conditional marketing authorisation.

“Once an application has been submitted, we will assess it under a timeline which will be reduced to the absolute minimum, meaning an opinion could come very soon.”

Guido Rasi, executive director of the EMA, said on 18 May 2020 that approval would be subject to the data submitted and whether experts deem it to be “robust enough”. He added that the marketing authorisation for the drug would only be conditional.

“I don’t see any other kind of approval at this stage,” he told the European Parliament.

The CHMP’s decision to start the rolling review of remdesivir was based on preliminary results from the US Advanced COVID-19 Treatment Trial study, which suggested a beneficial effect of remdesivir in the treatment of hospitalised patients with mild-to-moderate or severe COVID-19.

The aim of a rolling review is to speed up the assessment of a promising investigation medicine during a public health emergency, such as the ongoing COVID-19 pandemic.

Under normal circumstances, all data supporting a marketing authorisation application must be submitted at the start of the evaluation procedure. However, in the case of a rolling review, CHMP rapporteurs are appointed whilst development is still ongoing. The EMA reviews data as they become available.

Remdesivir — which inhibits RNA-dependent RNA polymerase and, therefore, interferes with RNA replication — is not yet authorised in the EU, but is available to patients through clinical trials and compassionate use programmes, which enable patients to get access to unauthorised medicines in emergency situations.

On 11 May 2020, the CHMP recommended expanding the compassionate use of remdesivir so that more patients with severe COVID-19 could be treated.

A spokesperson for the EMA said the organisation would “communicate further” about the conditional marketing authorisation when more information was available.