Sunday. 05.02.2023

EU approves Covid-19 drug remdesivir

Sold under the name Veklury, it is the first medicine to gain such a go-ahead for use in the EU.

Packs containing vials of Remdesivir, a broad-spectrum antiviral medication approved as a specific treatment for COVID-19, lie next to an employee of Egyptian pharmaceutical company Eva Pharma at the company's factory, which started producing the drug this week with a production capacity of up to 1.5 million doses per month. The European Commission says it has approved the use of the medication remdesivir to treat severe cases of Covid-19 in the European Union. Photo: Fadel Dawood/dpa
Packs containing vials of Remdesivir, at the company's factory in Egypt. Photo: Fadel Dawood/dpa.

The first drug to treat severe cases of Covid-19 in the European Union has been given the green light, with the European Commission approving remdesivir on Friday.

"We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus,” Stella Kyriakides, the EU's health commissioner, said in a statement.

It is the first time the EU's executive arm has granted the approval to a Covid-19 drug and was the last step for remdesivir to be given the full the go-ahead.

This decision follows a recommendation from the European Medicines Agency (EMA), which last week said that the drug - sold under the name Veklury - should be approved for treating Covid-19 patients over the age of 12 who require supplemental oxygen.

Remdesivir, manufactured by US biotech company Gilead Sciences, was originally developed as an Ebola treatment, but it had little effect.

Friday's approval comes shortly after the US government had announced an agreement with Gilead Sciences, according to which it bought up almost all of the drug supplies for the upcoming months. On Thursday, the European Commission said it was also in talks with the company to secure sufficient doses for the EU.

Effectiveness uncertain

But the effectiveness of the treatment remains uncertain. An international study at the end of April with over 1,000 participants showed that remdesivir could reduce the time needed for Covid-19 patients to recover from 15 to 11 days on average.

It also showed that mortality rates decreased slightly with the use of the drug, but not in a statistically significant way.

One Chinese scientific paper, meanwhile, reported no benefit of using remdesivir.

In coming weeks, the World Health Organization hopes to do a meta-analysis of ongoing and published studies.

To speed up the process of approval, the EMA began reviewing remdesivir on April 30 on a rolling basis. This means that the company will submit data as it becomes available.

Gilead submitted its official application for the limited approval of remdesivir on the European market in early June.

WHO calls for global solidarity

Amid discussions about which countries will be able to secure Covid-19 drugs for themselves, the WHO stressed the need for global solidarity.

"This is a test for all of humanity," Soumya Swaminathan, WHO chief scientist, said on Thursday.

Swaminathan also cautioned that clinical trials are still ongoing for the drug. "We don't know what the efficacy is," she said.

Hans Kluge, WHO's regional director for Europe, said last week that the continent had at the end of June seen the first increase in weekly cases in months.

The WHO European region covers 53 countries with a total of about 2.5 million cases.

EU approves Covid-19 drug remdesivir