NY-based biotechnology company Regeneron Pharmaceuticals has announced that its REGEN-COV prevents COVID infection by more than 81%, according to BioSpace.
The company announced positive findings from its ongoing Phase 3 trial on the use of REGEN-COV, revealing that it was able to reduce the risk for SARS-CoV-2 infection by 81.6% during the second to eighth month follow-up period and maintained an 81.4% risk reduction rate of 81.4% in the first month, per the news outlet.
Using Regeneron’s VelociSuite and VelocImmune technologies, REGEN-COV is a combination of two monoclonal antibodies that block the infectivity of the virus.
Last month, Regeneron announced that the Food and Drug Administration (FDA) approved its Biologics License Application (BLA) for REGEN-COV. It also said that the company was given until April 13, 2022, to take action.
Regeneron is conducting two Phase 3 trials on more than 6,000 patients to evaluate the drug’s efficacy as prophylaxis for asymptomatic people living with a person infected with the virus. The company is also studying the drug’s efficacy in people who are infected but not hospitalized.
The latest results refer to a pre-specified analysis during which 45 more symptomatic infections were observed.
The study showed that REGEN-COV has been playing a key role in preventing infection even without requiring more doses. During the study period, no participants were hospitalized while on REGEN-COV compared to the six who were under the control group.
Dr. Myron Cohen, who heads the monoclonal antibody efforts for COVID Prevention Network, said, “Today’s new data demonstrate how a single dose of REGEN-COV can help protect people from COVID-19 for many months after administration.”
“These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines including people who are immunocompromised,” added Dr. Cohen, who is also the director of the Institute for Global Health & Infectious Diseases at the University of North Carolina, Chapel Hill.
In the United States, the FDA has not yet fully approved REGEN-COV but it does hold an emergency use authorization (EUA) for people aged 12 and above.
REGEN-COV is also authorized to treat people who are at high risk for severe consequences associated with COVID-19.
Please note that the drug is not a substitute for vaccination or pre-exposure prophylaxis. It is also not a substitute for oxygen therapy in hospitalized patients.
