Roche/Regeneron REGEN-COV for COVID-19 post-exposure prevention!
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Roche/Regeneron antibody cocktail REGEN-COV has been reviewed by the US FDA as a priority: for treatment and post-exposure prevention!
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Roche/Regeneron REGEN-COV for COVID-19 post-exposure prevention!
COVID-19 epidemic: 240 million cases! The Roche/Regeneron antibody cocktail REGEN-COV has been reviewed by the US FDA as a priority: for treatment and post-exposure prevention!
REGEN-COV is the first antibody therapy that can be used for COVID-19 treatment and post-exposure prophylactic treatment.
News on October 15, 2021, Regeneron announced that the U.S. Food and Drug Administration (FDA) has accepted a biological product license application (BLA) for COVID-19 antibody cocktail therapy REGEN-COV (casirivimab and imdevimab) and granted priority review: (1 ) for the treatment of ambulatory patients COVID-19; (2) used in certain individuals, preventing COVID-19 .
The FDA has designated a target action date of April 13, 2022. The agency has notified Regeneron and is currently planning to hold an advisory committee meeting before that date to discuss the application. The second BLA is expected to be submitted later this year: for the treatment of COVID-19 hospitalized patients.
The BLA is supported by data from 2 positive phase 3 trials involving more than 6000 patients. These trials evaluated REGEN-COV: (1) for the treatment of non-hospital patients who have been infected with the novel coronavirus (SARS-CoV-2) ; (2) for the asymptomatic household contacts of SARS-CoV-2 infection ( Including uninfected and infected contacts) to prevent symptomatic infections.
In the European Union (EU), the regulatory submission of REGEN-COV is also making progress. Earlier this week, the European Medicines Agency (EMA) accepted a marketing authorization application (MAA) for REGEN-COV (named Ronapreve): for the treatment of infected non-hospital patients, or for certain individuals to prevent COVID- 19. In addition, Regeneron also plans to submit a Type II change: the use of REGEN-COV for the treatment of COVID-19 hospitalized patients.
In the United States, REGEN-COV has not yet been approved by the FDA , but it has been granted an emergency use authorization (EUA): for treatment in certain high-risk groups, and for post-exposure prevention.
REGEN-COV is an antibody cocktail therapy, invented by Regeneron and developed in cooperation with Roche. Roche is mainly responsible for the development and supply of regions outside the United States. REGEN-COV consists of two monoclonal antibodies (casirivimab and imdevimab), which target two independent, non-identical antibodies in the receptor binding region of the new coronavirus (SARS-CoV-2) spike protein (S protein).
Overlapping sites have a synergistic effect, which can reduce the risk of virus mutation and escape, and protect the population from virus variants with mutations in the S protein. In addition, data from preclinical studies indicate that casirivimab and imdevimab retain neutralizing activity against key emerging variants.
In July this year, REGEN-COV received the world’s first regulatory approval (fully approved, trade name: Ronapreve) in Japan for the treatment of mild to moderate COVID-19 patients through intravenous infusion.
In addition, REGEN-COV has received conditional approval in the UK. In addition, REGEN-COV is authorized for emergency use or temporary pandemic use in more than 40 countries around the world (including the United States, the European Union, India, Switzerland, and Canada).
Original source: FDA Accepts REGEN-COV® (casirivimab and imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19
Roche/Regeneron REGEN-COV for COVID-19 post-exposure prevention!
(source:internet, reference only)
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