On Friday, 22nd October, the United States Food and Drug Administration (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.
According to the FDA, “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″ including a 1,062-patient study by the National Institute of Allergy and Infectious Disease, which found that remdesivir reduced hospital stays to 10 days from 15 days, and helped reduce the risk of death in some patients who were receiving oxygen. The drug did not improve overall survival.
Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. The drug was originally developed to treat Ebola. Though the drug didn’t work well against Ebola, it showed promise against SARS and MERS – illnesses also caused by coronaviruses – in animals, which is why researchers thought remdesivir might help fight COVID-19
The US FDA authorized the drug for emergency use in the treatment of COVID-19 in May 2020.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “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 to 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.”
In April this year, Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said it “doesn’t seem like a knockout 100 percent,” but it could block the virus.
Remdesivir has been authorized for emergency use in India, Singapore,and approved for use in Japan, the European Union, the United States, and Australia for people with severe symptoms.
Despite this approval, the World Health Organisation (WHO) has expressed its concerns about the clinical trials used in the approval of this drug. WHO Chief Scientist, Soumya Swaminathan, said that the US did not consider all evidence, including a trial in which the medicine failed, before giving it the green light.
The FDA decision came a week after the release of the results of the World Health Organization’s Solidarity trial, which concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19.
The WHO says that its formal guidelines on use of remdesivir for COVID-19 should be ready for release in three to four weeks, after a separate group within the United Nations health agency reviews data from the study.
According to Jane Diaz, WHO’s top official for clinical care responses, in a news conference, “We would anticipate that the guidelines will be available within three to four weeks.” A WHO panel “will convene next week to look at the totality of the evidence” of the effectiveness of the drug, made by Gilead Sciences.
Gilead Sciences’ Chief Medical Officer, Merdad Parsey, in an open letter, said that it would have enough doses to treat “all clinically appropraite patients globally” next week.
