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U.S. health officials on Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental drug that U.S. President Donald Trump received last month. when he got sick.
The Food and Drug Administration has authorized the use of the drug Regeneron Pharmaceuticals Inc. to try to prevent the development of hospitalization and worsening of the disease in patients with mild to moderate symptoms.
The drug is given as a one-time treatment through an IV. The FDA has allowed its use in adults and children 12 years and older who weigh at least 88 pounds (40 kilograms) and who are at high risk of serious COVID-19 disease due to age or some other conditions medical.
Read more:
Regeneron: What we know about the experimental coronavirus drug Trump took
The emergency authorization allows for initiation of use of the drug while studies continue to establish its safety and efficacy. Early findings suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk of disease progression, the FDA said.
Regeneron said the initial doses will be made available to approximately 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug, but may have to pay part of the cost of administering the IV.
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Initial supplies are likely to be vastly outweighed by demand as the United States has passed 12 million reported cases, with the country facing what health experts say will be a dark winter due to the uncontrolled spread of the virus.
Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection has occurred. The drugs are concentrated versions of those that have been shown to do this best in laboratory and animal tests, and theoretically help the body start fighting the virus right away.
The Regeneron drug is a combination of two antibodies to increase the chances of it being effective. Earlier this month, the FDA gave emergency clearance to an Eli Lilly single-antibody drug that is still under study.
There is no way to know if the Regeneron drug helped Trump recover; has received a number of treatments, and most COVID-19 patients recover on their own.
FDA regulators have cleared the drug Regeneron using their emergency powers to rapidly accelerate the availability of experimental drugs and other medical products during public health crises.
In normal times the FDA requires “substantial evidence” to prove that a drug is safe and effective, usually through one or more large strictly controlled patient studies. But during public health emergencies, the agency can lower these standards and only demand that the potential benefits of an experimental treatment outweigh its risks.
The emergency clearance works as a temporary approval for the duration of the COVID-19 pandemic. To gain full approval, Regeneron will need to submit further research to fully define the drug’s safety and benefit to patients.
The White House saw the decision as a victory for Trump’s efforts “to provide cutting-edge treatments with very promising results to protect the health and safety of the most vulnerable Americans,” according to a statement by spokesman Michael Bars.
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AP health writer Matthew Perrone contributed to this report.
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© 2020 The Canadian Press
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