U.S. allows use of 1st drug shown to greatly help virus recovery
02 May, 2020
U.S. regulators on Friday allowed emergency make use of the first drug that appears 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 said in a statement that Gilead Science’s intravenous drug will be specifically indicated for hospitalized patients with “severe disease,” such as for example those experiencing difficulty in breathing 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 regarding getting something approved” said Hahn, calling the drug “an important 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 typically, for hospitalized COVID-19 patients.
The study of just one 1,063 patients may be the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir’s effects could possibly be rigorously evaluated.
Those given the drug could actually leave a healthcare facility in 11 days on average vs. 15 days for the comparison group. The drug also may help avert deaths, but the effect isn't yet large enough for scientists to learn for sure.
Dr. Sameer Khanijo, a critical care specialist, said he really 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 beginning 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 something that will help stem the tide of this disease.”
The FDA said preliminary results for federal researchers warranted Friday’s decision, though regulators acknowledged “there is limited information known about the safety and effectiveness of using remdesivir.”
The drug’s unwanted effects include potential inflammation of the liver and problems linked to its infusion, that could bring about nausea, vomiting, sweating and low blood 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 turn into a new standard of look after severely ill COVID-19 patients. The drug, which blocks an enzyme the virus uses to copy its genetic material, is not tested on people with milder illness.
The FDA authorized the drug under its emergency powers to quickly speed experimental drugs, tests and other medical products to patients during public health crises.
In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through a number of large, rigorously managed patient studies. But during public health emergencies the agency can waive those standards and require only an experimental drug’s potential benefits outweigh its risks.
Gilead has said it could donate its currently available stock of the drug and is ramping up production to make more. It said the U.S. government would coordinate distribution of remdesivir to places most looking for it.
No drugs are approved now 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 lawyer specializing in FDA issues. “But obviously they would like to understand this out to patients as fast as possible.”
The FDA previously allowed narrow usage 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 shown the drug works for that and it has significant safety concerns.
The FDA warned doctors late last month against prescribing the drug beyond hospital or research settings, because of risks of sometimes fatal heart unwanted effects.
Two small studies published Friday add to concerns about the malaria drug. Critically ill COVID-19 patients given hydroxychloroquine were prone to heart rhythm problems, and for most risks mounted when it had been combined with an antibiotic, the studies found.
Source: the-japan-news.com