"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 USA that is available for all appropriate patients in need".
Remdesivir, an antiviral that works by limiting SARS-CoV-2 replication, is indicated for hospitalized patients age 12 and up (and at least 40 kg [88.2 lbs]).
The FDA approval comes days after a study from the World Health Organization found no benefit of the drug in reducing early death or in preventing progression to serious disease among almost 3000 COVID-19 patients.
Most recently, the World Health Organization's large Solidarity trial showed that remdesivir did not reduce the risk of death, the chances of being put on a ventilator or the length of hospitalization compared with standard care. "Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic".
The FDA also noted the potential side effects that arise as a result of using the drug, which include potential liver injury and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.
Mr. Parsey also said the drug is either approved or has temporary authorization in about 50 countries around the world.
The drug can only be given to patients in a hospital or equivalent setting.
One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The NIAID study showed that remdesivir shortened recovery time of Covid-19 patients by five days, which was clinically meaningful, the ministry said.
"We believe our results are robust and we hope that people doing treatment guidelines and regulators around the world will take note of our study results in addition to other evidence", Swaminathan said at a WHO briefing, a day after USA regulators approved remdesivir for Covid-19. Patients with moderate disease who received a five-day course of remdesivir were 65% more likely to experience clinical improvement compared with a standard-of-care group.
According to Gilead, this result was most potent in patients who required oxygen at baseline - in this subgroup, patients receiving remdesivir achieved clinical recovery seven days faster than those in the placebo group, with a median time to recovery of 11 days for remdesivir and 18 days for placebo.
"We believe our results are very robust", Swaminathan said.
The company said in June that it would charge United States hospitals roughly $3,120 for most patients who need remdesivir. The drug did not improve overall survival. Treatment discontinuation, all-cause grade 3 and 4 AEs, and laboratory abnormalities were similar across groups.