FDA approves remdesivir as treatment for COVID-19 patients in hospital
The Food and Drug Administration on Thursday approved the antiviral drug remdesivir as a treatment for patients with COVID-19 who require hospitalization.
Given through an IV, remdesivir works to stop replication of SARS-CoV-2, the virus that causes COVID-19, according to the drug's manufacturer, California-based Gilead Sciences Inc. Previously authorized by the FDA for emergency use to treat COVID-19, the drug is now the first and only approved COVID-19 treatment in the United States, Gilead said in a release.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead CEO Daniel O’Day said in a statement. “It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.”
The drug cut the time to recovery by five days – from 15 days to 10 on average – in a large study led by the U.S. National Institutes of Health.
It had been authorized for use on an emergency basis since spring.
President Donald Trump was treated with remdesivir when he was hospitalized with COVID-19 earlier this month.
More:Trump COVID-19 treatment: President had stakes in Regeneron and Gilead, makers of antibody cocktail, Remdesivir
Remdesivir received a guarded endorsement in April from Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, when it was announced as a new tool in the fight against the virus at a presidential news conference.
The drug also is known by its brand name, Veklury.
"In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kilograms) for the treatment of COVID-19 requiring hospitalization," Gilead said in the statement.
"Veklury should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care," Gilead said.
Gilead’s chief medical officer, Dr. Merdad Parsey, said that “we now have enough knowledge and a growing set of tools to help fight COVID-19.”
The drug is either approved or has temporary authorization in about 50 countries, he noted.
A large study of patients hospitalized with COVID-19 conducted by the World Health Organization recently found that remdesivir had no effect on deaths, the need for ventilation or length of hospital stay, though some have criticized the research.
Contributing: The Associated Press