U.S. health officials on Saturday agreed to allow the emergency use of a second antibody drug to help the immune system fight COVID-19, an investigational drug President Donald Trump received when he was ill last month.
The Food and Drug Administration has authorized the use of the drug Regeneron Pharmaceuticals Inc. in an attempt to prevent hospitalization and worsening of the disease in patients with mild to moderate symptoms.
The drug is administered as a single course intravenously. The FDA has cleared its use in adults and children 12 years of age and older who weigh at least 88 pounds (40 kilograms) and who are at high risk of serious illness from COVID-19 due to age or certain other medical conditions.
Emergency clearance allows the drug to be started while studies continue to establish safety and efficacy. Early results suggest the drug may reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk for 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. These patients will not be billed for the drug, but may have to pay part of the cost of administering the IV.
Initial supplies are likely to be vastly outstripped by demand, as the United States topped 12 million reported cases as the country faces what health experts say is a bleak winter due to the uncontrolled spread of the virus. .
Antibodies are proteins that the body makes to target and help kill viruses, but it can take weeks for the best to form after infection. The drugs are concentrated versions of those that have been shown to be most suitable in laboratory and animal tests, and in theory help the body to start fighting the virus immediately.
The Regeneron drug is a combo of two antibodies to increase the chances that it will be effective. Earlier this month, the FDA gave emergency clearance to a single antibody drug from Eli Lilly that is also still under investigation.
There is no way to know if the Regeneron drug helped Trump recover; he’s received a host of treatments and most COVID-19 patients are recovering on their own.
FDA regulators have allowed the drug Regeneron to use their emergency powers to quickly accelerate the availability of investigational 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 and tightly controlled patient studies. But during public health emergencies, the agency may lower those standards and only require that the potential benefits of an investigational 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 additional research to fully define the drug’s safety and benefits for patients.
The White House called the move a victory for Trump’s efforts “to provide cutting-edge treatment with very promising results to protect the health and safety of Americans most vulnerable,” according to a statement from spokesperson Michael Bars.