Remdesivir gets FDA approval as the first coronavirus drug to treat hospitalized patients in the US
It will be given to people at least 12 years old and weighing at least 40 kg, who need hospitalization for their Covid-19 infection
The US Food and Drug Administration (FDA) has approved the antiviral drug remdesivir as a treatment for patients hospitalized with Covid-19. This makes it the first drug to receive full approval for treating the disease in the US. Currently, no other drugs are approved for treating Covid-19. The drug will be used for coronavirus patients who are at least 12 years of age, weigh at least 40 kg, and require hospitalization.
“Today, the FDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of Covid-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for Covid-19 to receive FDA approval,” says the agency.
Gilead Sciences’ remdesivir, sold under the brand name Veklury, was one of the drugs given to President Donald Trump after he was diagnosed with Covid-19. The FDA’s formal approval on Thursday, October 22 came just hours before the president’s final debate with Democratic rival Joe Biden ahead of the November 3 presidential election. Remdesivir costs $3,120 for a five-day treatment course or $2,340 for a five-day treatment course for people covered by government health programs.
“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. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks,” says FDA Commissioner Dr Stephen Hahn.
The drug was earlier authorized by the FDA in May for emergency use in the US. The emergency use authorization (EUA) was given after a large clinical trial showed that the drug reduces the time it takes for Covid-19 patients to be discharged from the hospital, as compared with a placebo treatment. The current approval “does not include” the entire population that had been authorized to use Veklury under the EUA. “In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for the treatment of suspected or laboratory-confirmed Covid-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing,” explains the agency.
What did the FDA say?
According to FDA and Gilead Sciences, the current approval is based on data from three randomized controlled trials. “Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use. In considering approval of a drug, the FDA conducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population. This is different from the standard used in the issuance of EUA. The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe Covid-19,” emphasizes the agency.
The data includes the recently published, final results of the National Institute of Allergy and Infectious Diseases’ (NIAID) double-blind, placebo-controlled Phase 3 ACTT-1 trial, which showed that treatment with Veklury resulted in “clinically meaningful improvements” across multiple outcome assessments compared with placebo in hospitalized patients with Covid-19. In the ACTT-1 trial, remdesivir improved time to recovery as compared to placebo – by five days in the overall study population (10 versus 15 days) and seven days (11 versus 18 days) in patients who required oxygen support at baseline. Based on the strength of these data, Veklury has become a standard of care for the treatment of Covid-19 in hospitals, states Gilead.
“Since the beginning of the Covid-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis. 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 US that is available for all appropriate patients in need,” says Daniel O’Day, chairman, and chief executive officer, Gilead. He adds, “We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with Covid-19 have the best chance at recovery.”
WHO study found remdesivir doesn't reduce deaths
The FDA move comes despite a recent analysis by the World Health Organization (WHO) which suggests that remdesivir has “little or no effect” on death rates among hospitalized patients as compared to standard medical care. According to the report, which has not been peer-reviewed, about 10.97% of coronavirus patients taking Remdesivir died in the clinical trial, versus 11.18% of patients receiving standard treatment. The drug also did not reduce hospital stay among coronavirus patients, it adds.
Commenting on the study, Gilead had said in a statement that the emerging data appear “inconsistent with more robust evidence” from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Remdesivir.