Express the prevention and treatment of COVID-19, and the neutralizing antibody combination obtains FDA priority review qualification

▎Editor of WuXi AppTec's content team On October 14, 2021, Regeneron announced that the US FDA has granted priority review of a biological product license application (BLA) for its neutralizing antibody combination therapy REGEN-COV (casirivimab+imdevimab) Eligible for the treatment of non-hospitalized COVID-19 patients and as a post-exposure prophylaxis therapy for high-risk populations
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The press release pointed out that if approved, it will be the first new coronavirus neutralizing antibody officially approved by the US FDA for the treatment of COVID-19 patients and as a post-exposure prophylaxis
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 REGEN-COV is a mixture of two monoclonal antibodies specifically designed to block the spread of the new coronavirus that causes COVID-19
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These two neutralizing antibodies can bind to the key receptor binding domain of the viral spike protein in a non-competitive manner, thereby reducing the ability of the mutant virus to escape treatment and preventing the human body from being attacked by the virus mutant
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Multiple analyses have shown that this neutralizing antibody therapy retains its efficacy against the main variants of interest, including Delta, Gamma, Beta, and Mu variants
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▲Casirivimab and imdevimab still maintain the ability to neutralize new coronavirus variants such as Delta (picture source: reference [3]) This application is supported by positive data obtained from two phase 3 clinical trials
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The two trials enrolled more than 6000 patients, and evaluated the effectiveness and safety of REGEN-COV in the treatment of non-hospital patients infected with the new coronavirus, as well as the prevention of household contacts of asymptomatic new coronavirus infections (including uninfected and uninfected patients).
Infected contacts)
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A previous study published in the New England Journal of Medicine showed that for household contacts of an infected person, subcutaneous injection of REGEN-COV can prevent 81.
4% of symptomatic infections and 66.
4% of all infections
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Moreover, REGEN-COV also reduces the duration of symptoms and high viral load
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It should be noted that the FDA pointed out that REGEN-COV cannot replace the new crown vaccination and can only be used for post-exposure prevention of adults and children (over 12 years old and weighing at least 40 kg)
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The most common side effect is injection site reactions.
At least 1% of subjects experienced itchy skin redness and ecchymosis, but no serious allergic reactions or allergic reactions that could be life-threatening
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Roche has reached a cooperation with Regeneron and is mainly responsible for the development and promotion of this neutralizing antibody therapy outside the United States
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The two companies said they will work with public health organizations to support the delivery of this innovative treatment to low- and middle-income countries
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Since the outbreak of the new crown epidemic, in the face of this global health crisis, the global pharmaceutical industry has responded quickly.
The development of a variety of prevention and treatment methods such as vaccines, neutralizing antibodies, and small molecule therapies has effectively curbed the expansion of the epidemic
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This neutralizing antibody is expected to provide people with new prevention and treatment options
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Reference: [1] FDA Accepts REGEN-COV® (casirivimab and imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19.
Retrieved October 14, 2021, from https:// fda-accepts-regen-cov-casirivimab-and-imdevimab-for-priority-review-for-treatment-and-prophylaxis-of-covid-19-301400260.
html[2] FDA authorizes REGEN-COV monoclonal antibody therapy for post -exposure prophylaxis (prevention) for COVID-19.
Retrieved October 14, 2021, from https:// therapy-post-exposure-prophylaxis-prevention-covid-19[3] Planas et al.
, (2021).
Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization.
Nature, https://doi.
org/10.
1038 /s41586-021-03777-9 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
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This article is not a treatment recommendation either
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If you need guidance on the treatment plan, please go to a regular hospital for treatment
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