(Photo Credits: Benjah-bmm27, Public domain, via Wikimedia Commons)
The U.S. Food and Drug Administration has approved the antiviral drug developed by Gilead Sciences called Veklury (remdesivir) as treatment for COVID-19, making it the first in the United States.
FDA Commissioner Stephen M. Hahn, M.D., said: “The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency.”
He added, “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.”
The announcement came this Thursday—October 22, 2020—and was released by FDA through their official website. Read it in full here.
On the other hand, Gilead Sciences said in a statement, “In the United States, Veklury 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 also reminded the general public that: “Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”
Veklury has already been granted temporary Emergency Use Authorization (EUA) by FDA way back in May. It has, since then, been used as emergency treatment for COVID-19 in approximately 50 countries worldwide.
Meanwhile, CNN said that Veklury has “shown, at best, a modest benefit for coronavirus patients.”
In CNN’s interview with Rick Bright, the former director of the Biomedical Advanced Research and Development Authority (BARDA) said, “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 added, “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.”
A study published in the New England Journal of Medicine showed that hospitalized patients who received remdesivir (brand name Veklury) recovered within 11 days as opposed to the usual 15 days.
According to CNBC, a five-day treatment course with Veklury costs $2,340 for patients “covered by government health programs and other countries’ health-care systems” while it costs $3,120 for U.S. patients with “private health coverage.”
It has been over 7 months since COVID-19 was recognized in March 11, 2020 as a pandemic by the World Health Organization (WHO).
As of this writing, statistics show that a total of 42,133,361 people around the world have contracted COVID-19 while the total number of deaths worldwide has already exceeded the one million mark at 1,144,589.
Globally, the U.S. has the most number of confirmed COVID-19 cases and deaths at 8,668,541 and 228,466 respectively.