The Food and Drug Administration has approved remdesivir as a coronavirus treatment for patients at least 12 years old.
Gilead Sciences’ antiviral drug is now the first and only fully approved treatment in the US for Covid-19.
Remdesivir will be given to Covid-19 patients who are at least 12 years old and will stay in the hospital, according to Gilead Sciences. The coronavirus pandemic has led to more than 41.3 million infections worldwide and more than 1 million deaths, based on the data compiled by Johns Hopkins University.
Shares of Gilead rose by more than 5% in after-hours trading.
“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 company said that remdesivir is approved or authorized for temporary use as treatment for coronavirus in 50 countries.
The medication will only be administered in a hospital or in a health-care setting that can provide acute care comparable with inpatient hospital care.
Remdesivir treatment distribution
In July, President Donald Trump announced that the US government will send Texas hospitals cases of remdesivir as Covid-19 deaths increase.
Trump said during a press briefing in Midland, Texas, that the 500 cases of antiviral drug remdesivir will be enough to treat 3,200 patients as the Lone Star State hit record highs.
emdesivir has reportedly lessened the recovery time of some hospitalized Covid-19 patients.
In May, remdesivir received an emergency use authorization from the FDA, allowing hospitals and doctors to give it to patients hospitalized with Covid-19.
Meanwhile, the Department of Health and Human Services said on June 29 that there has been a deal that gives the country more than 500,000 treatment courses of the antiviral drug for hospitals through September. The agency said that this represents 100% of Gilead’s predicted production for July and 90% of production for August and September.
Gilead Sciences is selling remdesivir to patients with private insurance in the US for $520 per vial and to federal insurance programs such as Medicare as well as foreign countries for $390 per vial. The company said that most of the patients treated with remdesivir take a five-day treatment course using six vials of remdesivir.
WHO's opinion on remdesivir
However, the World Health Organization (WHO) said that remdesivir has “little or no effect” on death rates among hospitalized coronavirus patients.
Findings from the WHO’s Solidarity Therapeutics Trial suggest that the remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon drug treatment regimens “appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.”
The study is considered the world’s largest randomized control trial of coronavirus treatments. WHO held the investigation in 405 hospitals across 30 countries on 11,266 patients, with 2750 having taken remdesivir.
“No study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics), initiation of ventilation or hospitalization duration,” the authors of the study wrote.
Randomized controlled trials are deemed as the “gold standard” of clinical studies because they can properly remove bias. However, the WHO study has not yet been peer-reviewed.
