Remdesivir has received a one-year conditional marketing authorization from the European Commission due to the urgency of the Covid-19 pandemic, which has infected at least 2.5 million people in Europe, and killed more than 500,000.
The intravenous drug, manufactured by US pharma company Gilead Sciences, is intended for adults and children over the age of 12 who require supplemental oxygen.
The authorization can subsequently be extended or made unconditional after more data is submitted, Sonia Choi, a Gilead representative, told me. That includes data from currently ongoing phase III clinical trials.
In recent days, the US government has come under international criticism for hoarding remdesivir. The drug, which is sold under the brand name Veklury, was initially developed as a treatment against the Ebola virus. It blocks RNA polymerase, an enzyme that a variety of RNA viruses including Ebola and SARS-CoV-2 use in order to replicate their genetic material. Remdesivir received emergency use authorization in the US in May after initial studies showed it shortened recovery time by an average of 4 days, or 31%, in patients with Covid-19.
“We understand the urgent need of patients in Europe and are working on multiple fronts to expand supply as quickly as possible,” Choi said.
“At this time, there is limited supply of remdesivir. However, many countries in Europe have access to remdesivir through existing programs, such as ongoing clinical trials, temporary exemptions, and compassionate use programs. We expect supply of remdesivir will increase substantially starting in July and will continue to increase through the end of this year and into next year.”
While having an authorized treatment is an important step in the fight against Covid-19 in Europe, it is no silver bullet.
“Remdesivir must be administered intravenously, which in practice translates to [the fact that] the only Covid-19 patients that received the drug are hospitalized,” Warner Greene, virologist at University of California, San Francisco, told me. Those in hospital are typically in the second phase of the disease progression, he explained, when an overly zealous immune response rather than the virus itself is doing most of the damage.
“What we really need is an oral or aerosolized version of remdesivir that could be given much early in the infection when the virus is in charge.”
Some have also criticized the hefty price tag of the treatment — $2,340 for a five-day treatment course in Europe and $3,120 in the US — compared to considerably cheaper alternatives that may also receive authorization soon, such as dexamethasone.
“Now that we know the results of the dexamethasone recovery trial, which were more profound in a subset of patients on mechanical ventilation or supplemental oxygen, the use of clinical use of remdesivir is looking less favorable than the much less expensive dexamethasone,” Gerald Evans, an infectious disease expert at Queen’s University in Canada, told me.
Evans pointed out that there are other promising compounds being investigated, such as the antiviral favipiravir, which is currently in clinical trials, and the antiparasitic drug ivermectin, which has shown early promise in preclinical studies.
Remdesivir is one of several recent developments in antiviral treatments, with Bavarian Nordic receiving a marketing authorization in Europe for its Ebola vaccine and ViiV Healthcare gaining FDA approval in the US for a novel HIV treatment in the past week.