US approves make use of 1st drug to greatly help virus recovery
U.S. regulators on Friday allowed emergency make use of the first drug that seems to help some COVID-19 patients recover faster, a milestone in the global seek out effective therapies against the coronavirus.
THE MEALS and Drug Administration cleared Gilead Science's intravenous drug for hospitalized patients with "severe disease," such as for example those experiencing breathing problems requiring supplemental oxygen or ventilators.
President Donald Trump announced the news headlines at the White House alongside Gilead CEO Daniel O'Day and Food and Drug Administration Commissioner Stephen Hahn.
"This is lightning speed when it comes to getting something approved" said Hahn, calling the drug "a significant clinical advance."
The FDA acted after preliminary results from a government-sponsored study showed that the drug, remdesivir, shortened enough time to recovery by 31%, or around four days on average, for hospitalized COVID-19 patients.
Those given the drug could actually leave a healthcare facility in 11 days typically vs. 15 days for the comparison group. The drug also may help avert deaths, but that effect isn't yet large enough for scientists to learn for sure.
Dr. Sameer Khanijo, a critical care specialist, said he wants to see additional studies to clarify the drug's benefit.
"I don't think that is a remedy yet, but I think it's starting to point us in the proper direction," said Khanijo of North Shore University Hospital in New York. "As a society it's nice to have a thing that will help stem the tide of this disease."
The FDA said preliminary results from the federal government study warranted Friday's decision, though regulators acknowledged "there is bound information known about the safety and effectiveness of using remdesivir."
The drug's side effects include potential inflammation of the liver and problems linked to its infusion, which could bring about nausea, vomiting, sweating and low blood circulation pressure. Information regarding dosing and potential safety issues will be provided to physicians and patients, the FDA said.
The National Institutes of Health's Dr. Anthony Fauci said Wednesday the drug would become a new standard of care for severely ill COVID-19 patients. Remdesivir, which blocks an enzyme the virus uses to copy its genetic material, has not been tested on people with milder illness.
The FDA authorized the drug under its emergency powers to quickly speed the option of experimental drugs, tests and other medical products during public health crises.
In normal times the FDA requires "substantial evidence" of a drug's safety and effectiveness, usually through one or more large, rigorously manipulated patient studies. But during public health emergencies the agency can waive those standards and require only an experimental treatment's potential benefits outweigh its risks.
Gilead has said it'll donate its available stock of the drug and is ramping up production to create more. It said the U.S. government would coordinate distribution of remdesivir to places that require it most.
No drugs are FDA-approved for treating the coronavirus, and remdesivir will still need formal approval.
The FDA can convert the drug's status to full approval if Gilead or other researchers provide additional data of remdesivir's safety and effectiveness.
"This is an extremely, very early stage which means you wouldn't have a much any kind of full approval at this stage," said Cathy Burgess, an legal professional focusing on FDA issues. "But obviously they would like to understand this out to patients as quickly as possible."
The FDA previously allowed narrow use of a malaria drug, hydroxychloroquine, for hospitalized patients who were not able to take part in ongoing studies of the medication. Trump repeatedly promoted it just as one COVID-19 treatment, but no large high-quality studies have displayed the drug works for that and it has significant safety concerns.
The FDA warned doctors late last month against prescribing the drug outside of hospital or research settings, because of risks of sometimes fatal heart unwanted effects. The agency made the announcements after obtaining new reports of injury and death with the medication, which is also used to take care of lupus and rheumatoid arthritis.
Two small studies published Friday increase concerns about hydroxychloroquine. Critically ill COVID-19 patients given the pill-based drug were prone to heart rhythm problems, and for many risks mounted when it had been coupled with an antibiotic, the studies found.
