Remdesivir can only be given to patients in a hospital or equivalent setting (representation)
Washington:
The United States Food and Drug Administration on Thursday granted full approval for remdesivir, an antiviral drug, as a treatment for hospital patients with Covid-19, after conditional clearance in May.
Gilead said the drug, sold under the brand name Veklury, was the only specific treatment for Covid-19 approved so far in a more rigorous process.
However, other treatments have received authorization for emergency use, although that approval may be revoked once the public health emergency triggered by the coronavirus pandemic is over.
Other drugs, like the steroid dexamethasone, are also used in the fight against Covid-19.
Gilead’s shares on the New York Stock Exchange jumped 4% soon after the announcement.
“The FDA is committed to accelerating the development and availability of Covid-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen Hahn.
“Today’s approval is supported by data from several clinical trials that the agency has rigorously evaluated and represents an important scientific milestone in the Covid-19 pandemic.
Europe and other countries like Canada have also granted temporary authorization for the use of remdesivir.
Remdesivir, given by injection, was one of the first drugs to show relatively promise in shortening healing time in some coronavirus patients.
But its effectiveness in reducing the death rate is not proven.
It can be given to adults and children over 12 who weigh more than 40 kilograms (88 pounds) who require hospitalization for treatment of Covid-19, the disease caused by the new coronavirus.
The drug can only be administered to patients in a hospital or equivalent setting.
Emergency authorization has been granted for its use in pediatric patients under 12 years of age weighing at least 3.5 kg.
President Donald Trump, who tested positive for coronavirus in early October, was treated with remdesivir at a military hospital outside of Washington, among other drugs.
Faster recovery time
The drug was first developed to treat Ebola, a viral hemorrhagic fever.
In February, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced it was dusting off remdesivir to investigate SARS-CoV-2, the pathogen responsible for Covid-19, because it had showed promise in animal tests against other SARS and MERS coronaviruses.
His study of more than 1,000 people, the results of which were released in April, found that patients on the drug had a 31% faster recovery time than those on placebo.
Since the drug is complex to manufacture and is administered by injection rather than pill, questions have arisen as to whether supply could be limited initially.
The United States capitalized on the success of remdesivir early on, rushing to pre-order almost all of Gilead’s summer production.
Gilead has set the price at $ 390 per vial in developed countries, or $ 2,340 for six vials used during the normal five-day cycle, although U.S. private insurers will pay $ 520 per vial.
(This story was not edited by GalacticGaming staff and is auto-generated from a syndicated feed.)
