U.S. FDA authorizes antibody cocktail therapy for covid treatment emergency use on 30 July 2021

 Research, editing : Gan Yung Chyan, KUCINTA SETIA

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FDA authorizes antibody cocktail treatment for emergency use on 30 July 2021

Image : REGEN-COV marketed as REGN-COV2 (Bill Oxford via Getty Images)

On 30 July 2021, the U.S. Food and Drug Administration (FDA) announces its authorization on the use of REGEN-COV monoclonal antibody therapy for post-exposure prevention for covid, marketed commercially in the name of REGN-COV2.

REGEN-COV is the cocktail product of two monoclonal antibodies casirivimab and imdevimab,  that are specifically directed against the spike protein of SARS-CoV-2 (novel coronavirus, covi), designed to block the virus’ attachment and entry into human cells.

FDA has revised the Emergency Use Authorization (EUA) for REGEN-COV for emergency use as post-exposure prevention for covid in adults and individuals aged 12 years old and above and weighing at least 40 kg who are at risk for progression to severe covid including hospitalization or death.

FDA stresses that REGEN-COV can only be used after positive exposure to covi (including the mutant variants), and determined after conventional viral testing. It is not a preventive treatment for covid before exposure to covi.

REGEN-COV is not a substitute for covi vaccination. FDA has authorized the Pfizer-BioNTech vaccine/Comirnaty, Moderna and Janssen vaccines to prevent covid and serious clinical outcomes caused by covid.

REGEN-COV is developed by Regeneron Pharmaceuticals and is the therapy applied to treat the 45th American President Donald Trump of covid last year months before the U.S. 2020 Election.

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Special emergency license first granted to REGEN-COV in November 2020 for its effectiveness against covid

The FDA in November 2020 granted a special emergency license to the antibody cocktail REGEN-COV for the treatment of mild to moderate covid in adults and children.

The current trial tested REGEN-COV for use as a passive vaccine, which involves the immediate delivery of antibodies to the virus to the body, as opposed to traditional vaccines in which the recipient's immune system is activated to develop its own antibodies.

REGEN-COV may be able to provide immediate passive immunity to those at high risk of infection, as opposed to active vaccines that take weeks to provide protection, the company said.

"These data on the use of REGEN-COV as a passive vaccine suggest that it can both reduce the transmission of the virus and reduce the burden of viruses and diseases on those who continue to be infected," said George Gankopoulos, of Greek descent. President and Chief Scientific Officer of Regeneron.

The company also expects REGEN-COV to help people who do not respond well to vaccination.

During trials conducted jointly by Regeneron and the National Institute of Allergy and Infectious Diseases, one covid-related death and hospitalization were reported among those receiving placebo, but there was no such incident in the group received treatment, according to the company.

Refs: https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19, https://www.huffingtonpost.gr/entry/regen-cov-apotelesmatiko-kata-toe-koronoioe-to-kokteil-antisomaton-tes-regeneron_gr_60102b76c5b61cb9534ec2b3?ncid=other_trending_qeesnbnu0l8