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Remdesivir closes in on receiving first EU approval for treatment for COVID-19

First drug shown to have an effect on COVID-19 in controlled clinical trials

Gilead

The EMA’s human medicines committee has recommended approval of Gilead Sciences’ antiviral drug, remdesivir, to treat patients with COVID-19 in the EU, making it the first coronavirus drug to reach that milestone.

The CHMP has recommended granting a conditional marketing authorisation to remdesivir under the Veklury brand name – the same used for the drug in Japan where it has approval under emergency use protocols.

The EMA typically follows a CHMP positive opinion with a full approval within a couple of months, but is expected to move quickly in this instance given the urgency of the pandemic, particularly as easing of lockdowns raises fears of a second wave of infections in Europe. Approval could come within a week, said the committee.

Remdesivir was reviewed in record time by the CHMP under its rolling review procedure, which allows data on a drug to be reviewed as it becomes available. It started the rolling review of remdesivir in April, well before Gilead formally filed for approval of the drug on 5 June.

Gilead’s drug was the first drug to be shown to have an effect on COVID-19 in controlled clinical trials, showing that it can reduce the time spent in hospital for patients hospitalised with severe COVID-19 symptoms – down to 11 days from around 15 – in the ACTT-1 trial run by the National Institute of Allergy and Infectious Disease (NIAID).

It hasn’t been proven to improve the chances of surviving the disease, however, and its effect on hastening recovery was only observed in patients with more severe COVID-19 disease, who saw their time to recovery cut from 18 to 12 days, according to the CHMP.

“This effect was not observed in patients with mild to moderate disease,” said the panel in a statement on the positive opinion, adding that no difference in recovery times was seen in patients who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation).

So far, the only drug that has reduced mortality in COVID-19 is dexamethasone, a low-cost generic steroid that cut the death rate for the most seriously-ill patients by 41% at 28 days in the large-scale RECOVERY trial.

Data from ACTT-1 on the proportion of patients who died up to 28 days after starting treatment are currently being collected for final analysis.

The CHMP recommends that treatment with remdesivir should start with a 200mg infusion on the first day, followed by one 100mg infusion a day for at least four days, and no more than nine days.

A second NIAID trial – ACTT-2 – is testing the combination of remdesivir with Eli Lilly’s anti-inflammatory JAK inhibitor Olumiant (baricitinib) in patients hospitalised with COVID-19.

Gilead meanwhile is running additional studies in other patient groups, including children, and will shortly start studies of an inhaled formulation of the drug that could be given to earlier-stage patients outside hospital.

Article by
Phil Taylor

26th June 2020

From: Research

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