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The FDA Approves Regeneron’s Drug For The Prevention

A Regeneron immunotherapy drug has been cleared by the FDA for emergency use in severe conditions for individuals who are immunocompromised or unvaccinated. As the health agency noted in a news release, REGEN-COV should only be given to patients who haven’t been fully vaccinated, don’t respond well to vaccination, or are living in institutional settings where they have a high risk of infection.

In addition to taking medications that could compromise their immune systems, these individuals might also have undergone treatments such as chemotherapy or have had organ transplants. About 3% of the American population might not respond to vaccination due to the drugs they are taking or the treatments they are undergoing.

The FDA Approves Regeneron’s Drug For The Prevention

​​A news release from Regeneron says REGEN-COV can be used by these groups in post-exposure settings and certain institutional settings. The FDA has authorized REGEN-COV to combat COVID infections in people who are at increased risk for infection. The president and chief scientist of Regeneron are Dr. Yancopoulos.

REGEN-COV showed an 81% reduction in symptoms of COVID-19 among healthy people living with people infected with the disease in phase 3 clinical trials, according to the FDA. Currently, the drug is used to treat infections after they have occurred.

The FDA Approves Regeneron's Drug For The Prevention

For its monoclonal antibodies – Casirivimab and imdevimab – Regeneron Pharmaceuticals has been granted an emergency use authorization that will be given together to adults and seniors over age 12 who have mild to moderate COVID-19. Those patients with a positive COVID-19 test and a high chance of developing severe COVID-19, such as those older than 65 or with certain chronic medical conditions, should receive post-infection treatment.

Its expanded authorization was based on a large clinical trial involving the monoclonal antibodies Casirivimab and imdevimab found in the Regeneron cocktail. In the American, Moldovan and Romanian studies, the participants were household contacts of people who were infected with Coronavirus within the last four days. In each of the groups, a single injection of Regeneron cocktail was given under the skin, while a placebo injection was given to the other group.

One out of every eight participants who were initially negative for Covid developed it within four weeks, compared to just one out of every five participants who received the placebo, meaning the risk amount for participants who received the antibody injection was 81 percent less. Those who developed symptoms benefited from the antibodies, as they helped them cure the coronavirus more quickly and reduced their symptoms’ duration.

As a result of the antibody injection, of the 204 participants who had the Coronavirus but were symptom-free upon enrollment in the study, their risk of developing Covid symptoms fell by 32 percent within four weeks after receiving it. In contrast, ten people who received the placebo ended up at the ER or were hospitalized.\

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Several immunocompromised people were included in the study. Despite this, the FDA has identified this population as candidates for prevention treatments. In addition, people who work at nursing homes or in prisons are at high risk of being exposed to infected individuals. A monthly antibody cocktail can be given to people who have an increased risk of exposure to the virus from close contacts.

A Regeneron official explained that the federal government covers the cost of the treatment. Individuals who are eligible for preventive treatment must be unvaccinated, at high risk of severe Covid-19, and in close contact with someone who has tested positive. Infectious disease expert Dr. Katharine Bar, from the University of Pennsylvania, says the FDA’s approval of preventative measures is reassuring for people at high risk for severe illnesses.

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