They granted final approval for hospitalized Covid-19 patients. It is administered intravenously.
The United States Food and Drug Agency (FDA) granted the final approval as first treatment against the new coronavirus to the antiviral of Gilead Remdesivir, to date the only one with authorization from the regulator to treat the disease.
In May, the antiviral of Gilead Sciences received the emergency authorization, a formula to allow the use during the pandemic of the treatment still in its experimental stage, and now the FDA has granted final approval for cases of hospitalized Covid-19 patients.
Remdesivir allowed shorter recovery periods in some severe cases of Covid-19, although the World Health Organization (WHO) recently considered, after analyzing provisional data, that the antiviral, as well as others that have been administered to covid patients -19, has an almost negligible impact on reducing mortality.
America’s leading epidemiologist, Dr. Anthony Fauci, has defended the use of Remdesivir, which is being administered to patients in the United States and with which President Donald Trump was treated during his convalescence at the beginning of the month.
With the authorization received this Thursday, Remdesivir becomes the only treatment authorized in the US for Covid-19, which infected more than 41 million people worldwide, although there are others that already have emergency authorization such as the use of plasma.
“It is incredible that in less than a year since the first reports of infected by the disease known as Covid-19 in the United States we have a treatment that is available to all patients who need it,” said the CEO of Gilead, Daniel O’Day.
Other treatments received authorizations for emergency use, which are temporary and granted based on less complete data than a full authorization, and can be revoked at the end of the state of health emergency, the AFP agency reported.
It can be given to adults and children over 12 years of age who weigh at least 40 kilos, in case they require hospitalization, and can only be administered by injection, in a medical center or equivalent setting.
Remdesivir was one of the first drugs to show relative efficacy in trials to shorten the recovery time of hospitalized patients by several days, although it has not been proven to reduce mortality.
The pharmaceutical expects to manufacture more than two million doses of the treatment this year and multiply that production capacity during 2021. For this, the company that specializes in cancer or HIV treatments has a network of suppliers and manufacturers all over the world.