By MARILYNN MARCHIONE, AP Chief Medical Writer
US health officials on Saturday agreed to allow the emergency use of a second antidote drug to help the immune system fight COVID-19, an experimental drug that President Donald Trump had taken ill last month Was given
The Food and Drug Administration authorized the use of the Regeneron Pharmaceuticals Inc. drug to prevent hospitalization in patients with mild to moderate symptoms and developing worsening disease.
The drug is given as a one-time treatment through an IV. The FDA has permitted its use in adults and children over 12 years of age who weigh at least 88 pounds (40 kg) and who are at high risk of serious illness from COVID-19 due to age or certain other medical conditions Are in
The emergency authority allows drug use to begin while studies are underway to establish safety and effectiveness. Preliminary results suggest that the drug may cause COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said.
Regeneron said the initial dose would be made available to about 300,000 patients through the federal government allocation program. Patients will not be charged for the drug but may have to pay some part of the cost of delivering the IV.
Initial supply will likely fall short of demand to a large extent as the U.S. has reported past 10 million cases, with health experts saying the country will have a dark winter due to uncontrolled spread of the virus.
Antibodies are proteins that the body targets and help eliminate the virus, but the best ones can take weeks to form after infection occurs. Drugs are concentrated versions of people who have proven to be the best at doing this in lab and animal tests, and in theory help the body to begin to fight the virus.
The Regeneron drug is a combo of two antibodies that will increase the likelihood that it will be effective. Earlier this month, the FDA granted emergency authorization to Eli Lilly’s single-immunity drug, which is still being studied.
There is no way to know if the Regeneration drug helped Trump recover; They received a host of treatments and cured most COVID-19 patients on their own.
FDA regulators authorized the Regeneron drug, using its emergency powers to accelerate the availability of experimental drugs and other medical products during public health crises.
In normal times the FDA requires “sufficient evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled studies. But during public health emergencies the agency can lower those standards and reduce the risks of the potential benefits of just one experimental treatment.
The emergency authority acts as a temporary approval for the duration of the COVID-19 epidemic. To win full approval, Regineron must submit additional research to fully define the safety of the drug and the benefit to patients.
AP health writer Matthew Peron contributed to this report.
The Associated Press Department of Health and Sciences has support from the Science Education Department of Howard Hughes Medical Institute. AP is solely responsible for all content.
Copyright 2020 The Associated Press. All rights reserved. This content may not be published, broadcast, rewritten or redistributed.