Coronavirus: Gilead's COVID-19 antiviral gets conditional EU approval

The European Commission (EC) granted conditional approval for the use of Gilead's (GILD) antiviral drug remdesivir in severe COVID-19 patients, making it the first medicine authorised by the body for treatment against the virus.

Remdesivir is an anti-viral drug that was developed for use against ebola. It has been approved for use in COVID-19 patients by the US and the UK, among other countries, after data suggested it can cut recovery time by about four days.

However, there is no clinical trial data as yet to suggest it improves survival chances. It costs around £430 ($536.81) for a treatment course of six doses.

Stella Kyriakides, EC commissioner for health and food safety, said the EC is determined “to respond quickly whenever new treatments become available.”

“We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus.”

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US pharmaceutical giant Gilead explained that under the EC’s new authorisation, remdesivir can be used for COVID-19 patients aged 12 years and older and weighing at least 40 kg, with pneumonia requiring supplemental oxygen.

It added that it is continuing with clinical trials to evaluate the medicine’s safety and efficacy. This includes studies of the drug in combination with anti-inflammatory medicines and in special populations including paediatric patients.

It is also researching the possibilities of using the drug in earlier stages of COVID-19.

Meanwhile, the UK said it has enough stocks of remdesivir, after the US bought nearly all the manufacturing stock for the next three months.

The Department of Health said it had secured supplies of remdesivir in advance and had enough to treat every NHS patient who needs it.

It comes after the US Department of Health and Human Services (HSS) said it had secured more than 500,000 treatment courses of remdesivir for American hospitals.

This represents 100% of the US pharmaceutical firm Gilead’s projected production for July (94,200 treatment courses), 90% of production in August (174,900 treatment courses), and 90% of production in September (232,800 treatment courses), alongside an allocation for clinical trials.