Remdesivir manufacturer Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved the drug for treatment of Covid-19. The drug has been used in hospitals for months to treat coronavirus patients after receiving emergency use authorization from the FDA earlier in the year.
“In the United States, Veklury (brand name for remdesivir) is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization,” the company said in a statement.
“Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”
Earlier in October, a global study sponsored by the World Health Organization (WHO) failed to find that remdesivir helped Covid-19 patients to survive or even recover faster than they would do without the assistance of the drug. However, a US study did find that the infused drug was able to potentially shorten recovery time by around a third.
Rick Bright, former director of the Biomedical Advanced Research and Development Authority (BARDA), said he was not impressed by remdesivir. “It’s important to note that even the data that we saw in the United States from that drug show that the benefit was modest,” Bright told CNN’s Wolf Blitzer last week.
“It wasn’t a home run. It wasn’t a remarkable improvement in terms of mortality, or even the lengthening or shortening of the length of hospital stay, but it did show some marginal benefit,” Bright said.
As part of the application to get FDA approval, Gilead Sciences submitted the study they published in the New England Journal of Medicine that demonstrated that remdesivir shortened the course of illness in patients hospitalized with coronavirus by an average of 15 to 11 days. Two further studies were considered by the FDA when making their decision, with one showing a slight benefit of the drug and another showing that it made little difference.
“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,” FDA Commissioner Dr. Stephen Hahn said in a statement.
“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.”
President Trump has long been a champion of remdesivir as a treatment for Covid-19 and in June the US bought up basically the entirety of the world’s supply for the following three months.
This move came under some criticism, partially because there had been no evidence suggesting that remdesivir was effective and partially because the US had bought almost the entire world supply, raising alarms over how the country may act when a vaccine or similar treatment is released.
Trump may now see this approval from the FDA as vindication, but there still remains doubt over the efficacy of remdesivir on Covid-19 patients.
“I’m pleased to announce that Gilead now has an EUA from the FDA for remdesivir. And you know what that is because that’s been the hot thing also in the papers and in the media for the last little while. An important treatment for hospitalized coronavirus patients,” Trump said in the Oval Office after remdesivir was granted emergency use authorization. “And it’s something — I spoke with Dr. Hahn and Dr. Fauci; I spoke with Deborah about it. And it’s — it’s really a very promising situation.
We’ve been doing work with the teams at the FDA, NIH, and Gilead for spearheading this public-private partnership to make this happen very quickly.”
“What I’d like to say is that, you know, on behalf of Gilead, to the President’s point, we feel a tremendous responsibility. We’re humbled by this being an important first step for patients, for hospitalized patients,” Mr O’Day said from Gilead Sciences.
“We want to make sure nothing gets in the way of these patients getting the medicine. So we made a decision to donate about 1.5 million vials of remdesivir.
“We’ll be working with the government to determine how best to distribute that within the United States. We’ll be working very closely to get that to patients, working with FEMA, working with other parts of the government to make sure that we get that to the patients in need as quickly as possible, because there are patients out there that can benefit from this medicine today that are hospitalized, and we don’t want any time to waste for that.
“And we’re also fully committed to continue to expand the supply of this medicine. We started investing in this back in January, as soon as we became aware of the coronavirus. This is a long time to manufacture. It used to be 12 months; it’s now 6 months. Our scientists have brought that down.”