Gilead Sciences, Inc. announced today that the United States Food and Drug Administration has approved remdesivir (also known as Velkury) to treat patients with COVID-19 who require hospitalization. Velkury is an antiviral medication that stops the replication of SARS-CoV-2, which is the virus that causes COVID-19. It is the first and only FDA approved treatment for coronavirus in the United States. Manufacturing has been dramatically increased and and expanded to allow for a sustainable supply for hospitals across the country.
Patients 12 years of age or older who weigh at least 88 pounds are approved to receive remdesivir as a treatment. They say it should only be administered in the hospital or a healthcare setting that is able to provide acute care similar to inpatient care.
After three randomized controlled trials that showed the treatment resulted in “clinically meaningful improvements” and was compared to a placebo, was the drug approved. In May, the FDA granted an emergency use authorization so that hospitals could use the drug to treat covid patients even though it hadn’t been approved yet. Shorter recovery time has been seen in patients who have been treated with it. Even President Donald Trump was treated with remdesivir while he was hospitalized at Walter Reed Medical Center for a few days after being diagnosed with coronavirus.
Barry Zingman, MD, praised the benefits of the drug and noted how amazing it is that there is now a treatment for the virus that has taken far too many people. He said that because of it, families now have hope to move forward.
Daniel O’Day is the Chairman and CEO for Gilead Sciences and he said, “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 U.S. that is available for all appropriate patients in need.”
He continued to say, “The speed and rigor with which Velkury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies, and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Velkury to ensure all patients with COVID-19 have the best chance at recovery.”
Sources: Breaking 911, CNBC; Photo-Fierce Pharma