New Trial Data: Regeneron’s Antibody Treatment Prevents COVID Infections
A potential treatment against the COVID-19 virus could be coming, but not in the form of another vaccine. Healthcare company Regeneron is seeking approval from the U.S. Food and Drug Administration for REGEN-COV as a preventative antibody treatment against the novel coronavirus.
Regeneron Phase 3 Trial Shows 81% Reduced Risk of Symptomatic Infections
According to data released by Regeneron, the phase 3 double-blind, placebo-controlled trial of the experimental drug suggests it could be effective in preventing symptomatic COVID-19 infections. After receiving a REGEN-COV injection, patients who were not infected when they entered the trial experienced an 81% reduced risk of symptomatic infection. The drug provided 72% protection against symptomatic infection during the first week and 93% in subsequent weeks, according to statement released by Regeneron.
“These data suggest that REGEN-COV can complement widespread vaccination strategies, particularly for those at high risk of infection,” Myron Cohen, M.D., director of the Institute for Global Health & Infectious Diseases at the University of North Carolina at Chapel Hill, said in the statement. “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.”
Although the “passive vaccine,” as Regeneron has referred to the treatment in past statements, shows promise, there are some reported downsides. Twenty percent of participants experienced adverse events, all of which were resolved, and four patients — two who received REGEN-COV and two who received a placebo — died during the testing phase. However, none of the deaths were attributed to the drug or placebo, and none of the participants dropped out of the trial due to the adverse events.
The study details will now be shared with the FDA for approval. There’s no timeline on when the FDA will consider the data, and no indication whether the drug will be approved as an effective preventative measure against COVID-19.
Study Data Comes Out as Johnson & Johnson Vaccine is Paused
The new information about REGEN-COV was released as the FDA and the Centers for Disease Control issued a statement recommending a pause on using the Johnson & Johnson vaccine, which received an emergency use authorization in February. After blood-clotting issues were discovered in six people who received the vaccine, the CDC announced it will investigate and “assess their potential significance.”
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