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WASHINGTON: US regulators on Friday allowed the emergency use of the first drug that appears to help some Covid-19 patients recover faster, a milestone in the global search for effective coronavirus therapies.
The Food and Drug Administration has approved Gilead Science’s IV drug for hospitalized patients with “serious illness,” such as those experiencing respiratory problems requiring supplemental oxygen or ventilators.
President Donald Trump announced the news at the White House alongside Gilead CEO Daniel O’Day and Food and Drug Administration Commissioner Stephen Hahn.
“This was lightning fast in terms of getting something approved,” Hahn said, calling the drug “a major clinical advance.”
The FDA acted after preliminary results from a government-sponsored study showed that the drug, remdesivir, shortened recovery time by 31%, or about four days on average, for hospitalized patients with Covid-19.
Those who received the medication were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug may also help prevent deaths, but that effect is not yet large enough for scientists to know for sure.
Critical care specialist Dr. Sameer Khanijo said he wants to see additional studies to clarify the drug’s benefit.
“I don’t think this is a cure yet, but I think it is starting to point us in the right direction,” said Khanijo of North Shore University Hospital in New York. “As a society, it’s good to have something to help stem the tide of this disease.”
The FDA said the preliminary results of the government study justified Friday’s decision, although regulators acknowledged that “limited information is known about the safety and efficacy of using remdesivir.”
The drug’s side effects include potential inflammation of the liver and problems related to its infusion, which can lead to nausea, vomiting, sweating, and low blood pressure. Doctors and patients will be informed about the dosage and possible safety concerns, the FDA said.
Dr. Anthony Fauci of the National Institutes of Health said Wednesday that the drug would become a new standard of care for seriously ill Covid-19 patients. Remdesivir, which blocks an enzyme that the virus uses to copy its genetic material, has not been tested in people with milder diseases.
The FDA authorized the drug under its emergency powers to quickly accelerate the availability of experimental drugs, tests, and other medical products during public health crises.
In normal times, the FDA requires “substantial evidence” of the safety and effectiveness of a drug, usually through one or more rigorously controlled, large patient studies. But during public health emergencies, the agency may waive those standards and demand only that the potential benefits of experimental treatment outweigh its risks.
Gilead has said he will donate his currently available stock of the drug and is increasing production to do more. He said the United States government would coordinate the distribution of remdesivir to the parts of the country that need it most.
Currently, there are no FDA-approved medications to treat 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 on the safety and effectiveness of remdesivir.
“This is a very, very early stage, so I wouldn’t expect to have any kind of full approval right now,” said Cathy Burgess, a lawyer specializing in FDA matters. “But they obviously want to communicate this to patients as quickly as possible.”
The FDA previously allowed the restricted use of an antimalarial drug, hydroxychloroquine, for hospitalized patients who were unable to participate in ongoing studies of the drug. Trump repeatedly promoted it as a possible Covid-19 treatment, but there are no large, high-quality studies that have shown the drug to work for that and have significant safety concerns.
The FDA warned doctors late last month not to prescribe the drug outside of the hospital or in research settings, due to the risks of sometimes fatal side effects. The agency made the announcements after receiving new reports of injury and death with the drug, which is also used to treat lupus and rheumatoid arthritis.
Two small studies published Friday add to concerns about hydroxychloroquine. Critically ill Covid-19 patients who received the pill-based medication were prone to heart rhythm problems, and for many risks increased when combined with an antibiotic, according to studies.
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The Food and Drug Administration has approved Gilead Science’s IV drug for hospitalized patients with “serious illness,” such as those experiencing respiratory problems requiring supplemental oxygen or ventilators.
President Donald Trump announced the news at the White House alongside Gilead CEO Daniel O’Day and Food and Drug Administration Commissioner Stephen Hahn.
“This was lightning fast in terms of getting something approved,” Hahn said, calling the drug “a major clinical advance.”
The FDA acted after preliminary results from a government-sponsored study showed that the drug, remdesivir, shortened recovery time by 31%, or about four days on average, for hospitalized patients with Covid-19.
Those who received the medication were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug may also help prevent deaths, but that effect is not yet large enough for scientists to know for sure.
Critical care specialist Dr. Sameer Khanijo said he wants to see additional studies to clarify the drug’s benefit.
“I don’t think this is a cure yet, but I think it is starting to point us in the right direction,” said Khanijo of North Shore University Hospital in New York. “As a society, it’s good to have something to help stem the tide of this disease.”
The FDA said the preliminary results of the government study justified Friday’s decision, although regulators acknowledged that “limited information is known about the safety and efficacy of using remdesivir.”
The drug’s side effects include potential inflammation of the liver and problems related to its infusion, which can lead to nausea, vomiting, sweating, and low blood pressure. Doctors and patients will be informed about the dosage and possible safety concerns, the FDA said.
Dr. Anthony Fauci of the National Institutes of Health said Wednesday that the drug would become a new standard of care for seriously ill Covid-19 patients. Remdesivir, which blocks an enzyme that the virus uses to copy its genetic material, has not been tested in people with milder diseases.
The FDA authorized the drug under its emergency powers to quickly accelerate the availability of experimental drugs, tests, and other medical products during public health crises.
In normal times, the FDA requires “substantial evidence” of the safety and effectiveness of a drug, usually through one or more rigorously controlled, large patient studies. But during public health emergencies, the agency may waive those standards and demand only that the potential benefits of experimental treatment outweigh its risks.
Gilead has said he will donate his currently available stock of the drug and is increasing production to do more. He said the United States government would coordinate the distribution of remdesivir to the parts of the country that need it most.
Currently, there are no FDA-approved medications to treat 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 on the safety and effectiveness of remdesivir.
“This is a very, very early stage, so I wouldn’t expect to have any kind of full approval right now,” said Cathy Burgess, a lawyer specializing in FDA matters. “But they obviously want to communicate this to patients as quickly as possible.”
The FDA previously allowed the restricted use of an antimalarial drug, hydroxychloroquine, for hospitalized patients who were unable to participate in ongoing studies of the drug. Trump repeatedly promoted it as a possible Covid-19 treatment, but there are no large, high-quality studies that have shown the drug to work for that and have significant safety concerns.
The FDA warned doctors late last month not to prescribe the drug outside of the hospital or in research settings, due to the risks of sometimes fatal side effects. The agency made the announcements after receiving new reports of injury and death with the drug, which is also used to treat lupus and rheumatoid arthritis.
Two small studies published Friday add to concerns about hydroxychloroquine. Critically ill Covid-19 patients who received the pill-based medication were prone to heart rhythm problems, and for many risks increased when combined with an antibiotic, according to studies.
