The European Medicines Agency (EMA) may grant an initial authorization of remdesivir as COVID-19 treatment soon, according to an EU official.
On Monday, Guido Rasi, the head of the European Union’s medicines agency, said that U.S. pharmaceutical company Gilead’s remdesivir could be granted as a COVID-19 treatment in coming days.
“It might be that a conditional market authorization can be issued in the coming days,” Rasi told a hearing in the EU Parliament in Brussels.
EMA already supported the utilization of remdesivir on a compassionate-use basis, which allows patients to take the drug even before its full authorization.
This initial authorization is called “accelerated approval” in the US. Gilead said it was talking to chemical and drug manufacturers for the distribution of remdesivir in Europe and Asia until at least 2022.
According to a Reuters article, Gilead is in negotiations with several generic drugmakers in India and Pakistan regarding long-term licenses and the production of the drug in developing countries.
However, the article states it is not yet clear how soon sufficient amounts of remdesivir as could be available to address the pandemic.
Efficacy of remdesivir
In the last week of April, Gilead Sciences reported that at least 50% of patients improved in their clinical trial.
The findings of the American biopharmaceutical company show that more than half of the patients recovered and left the hospital within two weeks.
Gilead also said another trial from the National Institute of Allergy and Infectious Diseases (NIAID) achieved its main goal. However, the company did not give more details at the time.
The NIAID’s drug trial showed “quite good news,” according to White House health expert Dr. Anthony Fauci. The remdesivir drug trial studied about 800 patients. Fauci also said remdesivir would set a new standard of care for COVID-19 patients.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is very important proof of concept,” Fauci said of remdesivir. “What it has proven is that a drug can block this virus.”
Meanwhile, the US Food and Drug Administration (FDA) is currently in “sustained and ongoing” discussions with Gilead to make remdesivir available to COVID-19 patients as quickly as possible, as appropriate,” according to FDA senior advisor Michael Felberbaum.
Access to remdesivir in the US
Meanwhile, in the US, hospitals are concerned about access to the drug. "We would like to see equitable and transparent distribution of this very precious resource," said Dr Helen Boucher, chief of infectious diseases at Tufts Medical Center in Boston.
Remdesivir remains available on a compassionate-use basis for pregnant women or children who are below 18. It will be available to most COVID-19 patients under the emergency use authorization.
"We participate in the Gilead clinical trials here at Tufts," Dr Boucher told Reuters. "We were notified that they will wind down ... no later than the end of May."
Gilead told Tufts it is shifting to product distribution under the emergency use authorisation.
In an article by Aljazeera, Gilead did not respond to requests for comment about the distribution of remdesivir.
However, on Saturday, the Department of Health and Human Services announced that Gilead pledged around 607,000 vials of remdesivir to hospitals in the US.
