The United States Food and Drug Administration (FDA) has recently announced their emergency approval of the unproven antibody treatment which medical professionals provided President Donald Trump last month after his positive test for the coronavirus.
Regeneron Pharmaceutical designed its drug to combat severe diseases in infected people. The treatment imitates the human body’s natural defenses instead of waiting for a natural protective immune response.
The experimental drug is the second that the FDA has approved for emergency use for the deadly COVID-19 virus. On November 9, the agency approved Eli Lilly & Co’s drug in a desperate attempt to curb the virus’s threat.
The drug that Regeneron produced contains a mixture of two monoclonal antibodies; casirivimab and imdevimab. The FDA had previously said that the experimental combination might be effective in treating adults and children aged 12 years and above suffering from mild to moderate coronavirus symptoms. Additionally, the agency noted the untested drug would be used to prevent much more severe cases from worsening.
However, similar to the first approved experimental drug, Regeneron’s treatment is time-consuming and complicated to produce. Officials expect a very short supply during distribution. Experts have expressed their concerns that the difficulties of producing the drug and its lack of quantity would stifle its delivery to high-risk patients.
Earlier this month, executives of the pharmaceutical company said they expected to produce enough doses to supply about 80,000 patients by the end of November and a total of 300,000 by the end of January.
On October 2, medical professionals gave U.S. President Donald Trump, who was diagnosed with the coronavirus, an infusion of Regeneron’s experimental drug. Despite not being approved for emergency use, the Republican was able to receive the treatment through a compassionate use program.
On Friday, Housing Urban Development Secretary Ben Carson said that through Trump’s intervention, he was also able to receive approval to be given the experimental drug. The official said, “which I am convinced saved my life.”
After his release from the hospital, Trump quickly announced the unproven treatment to be a cure for the coronavirus, which spread throughout social media, despite no evidence supporting his claims. The FDA did not take action on the president’s statement until several weeks later.
Regeneron’s drug was manufactured in cells from genetically engineered hamster cells and is a combination of two monoclonal antibodies. The experimental treatment was able to reduce hospitalizations or emergency room visits during a clinical trial. Tests also showed the drug reduced the amount of the COVID-19 virus inside infected people’s systems. The pharmaceutical company said it would continue tests.
On October 28, the New England Journal of Medicine researchers published a study that found Eli Lilly & Co.’s combination drug reduced the risk of follow-up medical visits. The analysis also observed lower levels of coronavirus among patients suffering from mild to moderate symptoms, the San Francisco Gate reported.
However, with the FDA granting approval for emergency use to Regeneron’s experimental drug, supply is the crucial factor that hinders distribution to the whole of the United States. Lilly had already allocated 40% of its bamlanivimab to several states across the country.
Federal officials said that the number of doses that would be distributed to each state is dependent on the number of confirmed cases and hospitalizations during a given week. Health and Human Services Secretary Alex Azar said during a previous briefing that the experimental treatments could save thousands of Americans and support the strained health-care system.
The director of the Duke-Margolis Center for Health Policy, Mark McClellan, said, “You can’t send them to places where cancer patients are being treated,” citing the distribution of the untested drugs. Experts warned that the treatments could be given to infusion clinics that are also housing patients with compromised immune systems.
