The Food and Drug Administration allows the use of 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 administered as a single treatment by IV. The FDA authorizes its use in adults and children over 12 years of age who weigh at least 40 pounds and who are at high risk for severe COVID-19 disease due to age or certain other medical conditions.
The emergency authorization allows the use of the medicine to start while the safety and efficacy studies continue. Early results suggest that the drug may reduce hospitalizations or emergency room visits in patients at high risk of disease progression, the FDA said.
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Regeneron said the initial doses would be given to about 300,000 patients through a federal government distribution program. These patients will not be charged for the medicine, but may have to pay part of the cost of IV.
Initial deliveries are likely to be significantly exceeded by demand, as the United States has exceeded 12 million reported cases, and the country will face a gloomy winter due to the uncontrolled spread of the virus.
Antibodies are proteins that the body creates to target and help eliminate viruses, but it can take weeks for the best to form after an infection. Medications are concentrated versions of those that have been shown to be best able to do this in laboratory and animal tests, and in theory help the body begin to fight the virus immediately.
Regeneron is a combination of two antibodies to increase the chances of being effective. Earlier this month, the FDA gave an emergency authorization for a drug with one antibody from Eli Lilly, which is also still being studied.
There is no way to know if Regeneron helped Trump recover; he received numerous treatments and most patients with COVID-19 recovered on their own.
FDA regulators have authorized the drug Regeneron, using their emergency powers to quickly accelerate the availability of experimental drugs and other medical products during public health crises.
Normally, the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, tightly controlled patient studies. However, during public health emergencies, the agency may lower these standards and require only the potential benefits of experimental treatment to outweigh the risks.
The emergency authorization functions as a temporary approval for the duration of the COVID-19 pandemic. To gain full approval, Regeneron will need to submit further studies to fully determine the safety of the medicine and the benefit to patients.
The White House declared the decision 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,” spokesman Michael Bars said in a statement.
AP health writer Matthew Perone contributed to this report.
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