FDA Gives Emergency Authorization For Some COVID-19 Patients To Use Remdesivir
Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug is still being studied.
During a meeting in the Oval Office of the White House with President Donald Trump, Gilead Chief Executive Daniel O'Day called the move an important first step and said the company was donating 1.5 million vials of the drug to help patients.
Another study published earlier this week by The Lancet found that COVID-19 patients treated with remdesivir were twice as likely to develop severe breathing problems, including acute respiratory distress syndrome, than those treated with placebo.
The FDA wrote that possible side effects include, "increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering".
The authorization means remdesivir can be distributed in the USA and given intravenously to treat COVID-19 patients - both adults and children - who are hospitalized with severe disease, the FDA says.
The data, Fauci told reporters earlier this week, "shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery" of Covid-19 patients. But during public health emergencies the agency can waive those standards and require only that an experimental drug's potential benefits outweigh its risks. It said the US government would coordinate distribution of remdesivir to places most in need of it. Citing the drug's limited supply, the company said hospitals with intensive care units and other hospitals that the government deems most in need will receive priority.
The donation is expected to be enough for at least 140,000 patients, depending on the number of days they need to be treated.
"Given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus now outweigh the known and potential risks of the drug's use", the FDA wrote in a press release.
The FDA can convert the drug's status to full approval if Gilead or other researchers provide additional data of remdesivir's safety and effectiveness.
It is not yet licensed or approved anywhere globally while multiple Phase 3 studies are ongoing to determine the safety and efficacy of the drug for the treatment of COVID-19.
It has only been used for the most severe cases of COVID-19, and is only administered through an IV. The AP is exclusively responsible for all content.