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Gilead Sciences gets the nod from the FDA for COVID-19 treatment

by | Oct 22, 2020

It would seem the race to find a suitable treatment for COVID-19 is over, as Gilead Sciences (GILD.Q) announced today that their antiviral drug Veklury (remdesivir) received the nod from the U.S. Food and Drug Administration today for treatment of patients requiring hospitalization.

It’s important to note first that Veklury isn’t a cure.  What it does is stop the SARS-CoV-2, the virus behind COVID-19, from replicating. It received the nod previously from the FDA for emergency use, and now it’s the first and only approved treatment in the United States. The drug is now widely available in hospitals across the country. And yes, it’s what the the POTUS and FLOTUS were given when they came down with COVID-19.

“The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources. The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalized patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need,” said Barry Zingman, MD, Professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center, New York.

It’s meant for treating adults and children, 12 years or older and at least 40 kilograms, for COVID-19 involving hospitalization. The literature on it has recommendations that it be administered in a hospital or healthcare setting capable of providing inpatient care.

The approval is the result of three randomized controlled trials involving 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 using the drug brought about improvements compared to placebo. Veklury has since become standard of care to treat COVID-19 based on this data.

“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. The speed and rigor with which Veklury 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 Veklury to ensure all patients with COVID-19 have the best chance at recovery,” said Daniel O’Day, chairman and chief executive officer, Gilead Sciences.

If you’re of a particularly science-loving bent, you can find the specifics published in the New England Journal of Medicine. For the rest of us, Veklury is a result of their decade-long antiviral research. It’s shown to have antiviral effects both in vitro and in vivo in animal models against pathogens like Ebola, SARS, Marburg, MERS, and SARS-CoV-2. The drug’s been approved or authorized for temporary use as treatment for COVID-19 in 50 countries worldwide, and the company intends to develop effective treatments for the disease throughout the multiple ongoing international Phase 3 clinical trials presently going on to evaluate the drug’s safety and efficacy.

So does that necessarily mean we can throw away our facemasks, start congregating in groups of more than six and resume normal distances? Well. No. The likelihood is that the average person isn’t going to be able to afford it. Jonas Salk these guys are not and at last look Veklury cost roughly $390 per vial, which is the government price. Since most hospitals aren’t government purchasers, they’ll be paying $520 per vial, which is a price they’ll naturally push onto you if you ask for it.

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