Regeneron Pharmaceuticals will request federal approval to use its antibody treatment as a preventative measure after researchers found it significantly reduced the risk that healthy trial volunteers exposed to COVID-19 would develop the disease.
“These antibodies may be particularly useful in individuals who are not yet vaccinated, and may also have potential in those who are immunosuppressed and may not respond well to vaccines,” said Dr. Dan Barouch, co-principal investigator of the Regeneron trial.
Researchers determined that the treatment, consisting of four injections, reduced the risk that volunteers exposed to COVID-19 would develop the disease by 81%.
Regeneron is seeking to expand its use authorization to be used as a preventative measure for people who have been exposed to the coronavirus.
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Monoclonal antibody therapies have been shown to considerably reduce the risk of severe disease and death due to COVID-19 by using lab-made proteins that the body produces to defend itself against infection. The Food and Drug Administration authorized antibody treatments from Regeneron and Eli Lilly in February for the treatment of mild to moderate COVID-19 in adults and children as young as 12 who are at high risk of getting seriously ill. Some high-profile patients, such as former President Donald Trump and former New Jersey Gov. Chris Christie, got it much earlier. Yet, the therapy is still not in widespread use in the U.S.
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Of the total 1,505 healthy volunteers enrolled in the phase 3 trial, 11 treatment recipients developed COVID-19 compared with 59 of those who received placebo shots. Those treatment recipients who did develop the disease saw their symptoms resolve after one week. Placebo recipients who got sick, meanwhile, saw their symptoms resolve after three weeks.
“If authorized, convenient subcutaneous administration of REGEN-COV could help control outbreaks in high-risk settings where individuals have not yet been vaccinated, including individual households and group living settings,” said Dr. Myron Cohen, leader of the monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network.
