Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19

Abstract

In an international National Institutes of Health–sponsored trial of combination SARS-CoV-2 neutralizing antibodies, investigators determined not only overall efficacy and safety but also whether there was a benefit of administration more than 5 days after symptom onset.

Evolution of the SARS-CoV-2 Omicron Variants: Genetic Impact on Viral Fitness

“…Regdanvimab, developed by Celltrion Inc. (Incheon, Republic of Korea), as well as the cocktail therapies Bamlanivimab/Etesevimab and Casirivimab/IImdevimab, developed by Eli Lilly and Regeneron respectively, have all forfeited their neutralization against BA.1 or BA.2. GSK’s Sotrovimab, and the cocktail therapies Amubarvimab/Romlusevimab (only approved in China, but both randomized controlled trials and real-world research robustly substantiate its clinical efficacy [ 64 , 65 , 66 ]) and Evusheld (Cilgavimab/Tixagevimab), developed by Brii Biosciences and AstraZeneca respectively, have also experienced varying degrees of decline in neutralizing activity, albeit still retaining some level of neutralization. In contrast, Eli Lilly’s Bebtelovimab, which gained approval after the appearance of Omicron on 11 February 2022, has demonstrated high-efficiency neutralizing activity against BA.1 and BA.2 [ 67 , 68 , 69 ].…”

Impact of structural modifications of IgG antibodies on effector functions

“…The anti-C5 complement inhibitor ravulizumab was recently approved ( 272 ), exhibiting a serum half-life of 56.6 days in patients with generalized myasthenia gravis ( 273 ). In addition, The LS variant has also been incorporated in neutralizing monoclonal antibodies (tixagevimab, cilgavimab amubarvimab and romtusevimab) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ( 274 , 275 ), all with an extended half-life.…”

Current development of severe acute respiratory syndrome coronavirus 2 neutralizing antibodies (Review)

“…Furthermore, The State Drug Administration of China has authorized Amubarvimab and Romlusevimab cocktail therapies, which were designed for treating adults or young individuals (12–17 years old, weight ≥40 kg) with mild and common types of SARS-CoV-2 infection who are at high risk of developing severe type infections ( 29 ). This treatment strategy is now serving a pivotal role in the clinical treatment process in Chinese hospitals to reduce incidence of serious adverse events ( 30 ). Compared with convalescent plasma, these types of NAbs confer a number of distinct advantages.…”