EU to authorise drug remdesivir for severe Covid-19 cases

The “conditional marketing authorisation” was released this week (Thursday June 25). This means that the drug can be sold in the EU for use against Covid-19 for a year, pending a “fast track” approval from the European Commission, which is expected within a week.

This approval allows “early access to medicines that fulfil an unmet medical need, including in emergency situations in response to public health threats such as the current pandemic”, the EMA wrote.

“This type of approval allows the Agency to recommend a medicine for marketing authorisation with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk.”

Remdesivir is the first drug to receive EMA authorisation since the start of the Covid-19 health crisis.

It will be sold in Europe under the name Veklury, for an as-yet-unknown price, and will be authorised for use for adults and adolescents from 12 years of age, who have Covid-19-related pneumonia that requires treatment with extra oxygen.

Scientific data

The EMA made its decision based on findings from scientific evaluations including an American study supported by the US Institute of Allergy and Infectious Diseases (NIAID), “plus supporting data from other studies”, the EMA said.

It explained: [The study] evaluated the effectiveness of a planned 10-day course of remdesivir in over 1,000 hospitalised patients with COVID-19.

“Remdesivir was compared with placebo (a dummy treatment) and the main measure of effectiveness was patients’ time to recovery (defined as no longer being hospitalised and/or requiring home oxygen or being hospitalised but not requiring supplemental oxygen and no longer requiring ongoing medical care).

“Overall, the study showed that patients treated with remdesivir recovered after about 11 days, compared with 15 days for patients given a placebo.”

The same effect was not true of patients with “mild to moderate disease”, however, only reduced recovery time for patients with severe disease. Similarly, the EMA said: “No difference was seen in time to recovery in patients who started remdesivir when they were already on mechanical ventilation.”

It concluded: “Taking into consideration the available data, the Agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease.”

Risk management

Under this kind of authorisation, the drug will be under “risk management” assessment.

Its manufacturer will be required to submit reports to the EMA on its safety and mortality by August 2020, and further data on its effectiveness by December this year (2020).

Remdesivir - manufactured by US laboratory Gilead - was first developed to treat the hemorrhagic fever virus Ebola. It is the first drug to appear effective and safe in treating patients with Covid-19, according to a significant clinical trial, with the benefits outweighing the risks.

It has already been approved for use in the US, and Japan.

The authorisation comes after another drug that had been initially posited as potentially effective against Covid-19, hydroxychloroquine, was later banned after studies suggested it may even increase, rather than decrease, the risk of mortality. There is still a lack of consensus.

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