Remdesivir, the much-talked-about experimental drug used to treat COVID-19 patients, has been conditionally approved by Europe’s top health care regulator, becoming the first drug to be “recommended for authorization” on the continent.
The European Medicines Agency (EMA) said that its human medicines committee (CHMP) has recommended the drug, which will be known as Veklury, for treating COVID-19 “in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen,” according to a statement on the EMA’s website.
“Remdesivir is recommended for a conditional marketing authorization, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfill an unmet medical need, including in emergency situations in response to public health threats such as the current pandemic,” the EMA said in the statement.
In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States. Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material. (Gilead Sciences via AP)
“This type of approval allows the Agency to recommend a medicine for marketing authorization with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk inherent to the fact that not all the data are yet available,” the EMA continued.
With the CHMP recommendation, the European Commission is expected to “fast-track the decision-making process” for marketing and allowing doctors to prescribe the drug “in the coming week.”
The price of the drug, manufactured by Massachusetts-based Gilead Sciences, was not disclosed in the release. However, Reuters reported the drug could be priced up to $5,080 per course in the U.S., while Indian generic drugmakers could sell treatments for 5,000 to 6,000 rupees ($66.13-$79.35).
Fox News has reached out to Gilead with a request for comment on this story.
Earlier this week, Gilead CEO and Chairman Daniel O’Day explained in an open letter the company expects “to have more than two million remdesivir treatment courses manufactured by the end of the year and many millions more by 2021.”
In the letter, O’Day added that remdesivir, which is currently given to patients intravenously, was set to be tested in an inhaled version.
The biotech giant said recently it is working with “leading chemical and pharmaceutical companies” to make sure remdesivir is available in Europe, Asia and the developing world. It previously announced that it set up licensing agreements with nine generic drug manufacturers. It has previously donated its entire existing supply.
Earlier this month, a Phase III trial of remdesivir showed that 65 percent of moderately ill patients had improvement after 11 days.
A separate study from the National Institutes of Health published in late May also showed the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received the placebo.
The antiviral was previously used to treat Ebola patients and has been garnering massive attention as the world scrambles to contain the coronavirus pandemic. Experts, however, warn that people should not take drugs unless prescribed by a doctor.
As of Thursday morning, more than 9.4 million coronavirus cases have been diagnosed worldwide, more than 2.3 million of which are in the U.S., the most impacted country on the planet.