Regdanvimab: First Approval

Syed, Yahiya Y.

doi:10.1007/s40265-021-01626-7

Cited by 47 publications

(37 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Regdanvimab received its first full approval on 17 September 2021 in South Korea for the treatment of COVID-19 in adult patients aged >50 years with at least one underlying medical condition (obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients on immunosuppressive agents) and mild symptoms of COVID-19, and in adult patients with moderate symptoms of COVID-19 [ 85 ]. Regdanvimab was granted marketing authorization by the EMA in November 2021 and is indicated for the treatment of patients with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.…”

Section: Nabs In the Treatment Of Sars-cov-2 Infectionmentioning

confidence: 99%

Monoclonal antibody therapies in the management of SARS-CoV-2 infection

Míguez‐Rey

Choi

Kim

et al. 2022

Expert Opinion on Investigational Drugs

View full text Add to dashboard Cite

Introduction Neutralizing antibodies (NAbs) that target key domains of the spike protein in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may have therapeutic value because of their specificity. Depending on the targeted epitope, single agents may be effective, but combined treatment involving multiple NAbs may be necessary to prevent the emergence of resistant variants. Areas covered This article highlights the accelerated regulatory processes established to facilitate the review and approval of potential therapies. An overview of treatment approaches for SARS-CoV-2 infection, with detailed examination of the preclinical and clinical evidence supporting the use of NAbs, is provided. Finally, insights are offered into the potential benefits and challenges associated with the use of these agents. Expert opinion NAbs offer an effective, evidence-based therapeutic intervention during the early stages of SARS-CoV-2 infection when viral replication is the primary factor driving disease progression. As the pandemic progresses, appropriate use of NAbs will be important to minimize the risk of escape variants. Ultimately, the availability of effective treatments for COVID-19 will allow the establishment of treatment algorithms for minimizing the substantial rates of hospitalization, morbidity (including long COVID) and mortality currently associated with the disease.

show abstract

Section: Nabs In the Treatment Of Sars-cov-2 Infectionmentioning

confidence: 99%

Monoclonal antibody therapies in the management of SARS-CoV-2 infection

Míguez‐Rey

Choi

Kim

et al. 2022

Expert Opinion on Investigational Drugs

View full text Add to dashboard Cite

show abstract

“…Did. The dose of Regdanvimab is a single intravenous infusion of 40 mg/kg ( Syed, 2021 ). A double-blind, placebo-controlled, randomized, phase II study, BLAZE4 (NCT04634409), found the efficacy of other mAbs, including bumlanivimab (700 mg) and sotrovimab (500 mg), for the treatment of symptoms.…”

Section: Regdanvimabmentioning

confidence: 99%

“…Low-risk, non-hospitalized COVID 19 patients. Preliminary results showed that bablanivimab/sotrovimab (700/500 mg) showed 70% (p <0> 5.27; day 7 cycle threshold <27.5 vs. placebo) ( Syed, 2021 ). A recent study compared and evaluated all published studies investigating SARS-CoV-2 neutralized mAbs (single or combined vs. active comparator, placebo, or no intervention) for the treatment of patients with COVID19 and “to the evidence.…”

Section: Regdanvimabmentioning

confidence: 99%

See 1 more Smart Citation

SARS-CoV-2: Recent Variants and Clinical Efficacy of Antibody-Based Therapy

Singh

Sharma

Lee

et al. 2022

Front. Cell. Infect. Microbiol.

View full text Add to dashboard Cite

Multiple variants of SARS-CoV-2 have emerged and are now prevalent at the global level. Currently designated variants of concern (VOCs) are B.1.1.7, B1.351, P.1, B.1.617.2 variants and B.1.1.529. Possible options for VOC are urgently required as they carry mutations in the virus spike protein that allow them to spread more easily and cause more serious illness. The primary targets for most therapeutic methods against SARS-CoV-2 are the S (Spike) protein and RBD (Receptor-Binding Domain), which alter the binding to ACE2 (Angiotensin-Converting Enzyme 2). The most popular of these strategies involves the use of drug development targeting the RBD and the NTD (N-terminal domain) of the spike protein and multiple epitopes of the S protein. Various types of mutations have been observed in the RBDs of B.1.1.7, B1.351, P. and B.1.620. The incidence of RBD mutations increases the binding affinity to the ACE2 receptor. The high binding affinity of RBD and ACE2 has provided a structural basis for future evaluation of antibodies and drug development. Here we discuss the variants of SARS-CoV-2 and recent updates on the clinical evaluation of antibody-based treatment options. Presently, most of the antibody-based treatments have been effective in patients with SARS-CoV-2. However, there are still significant challenges in verifying independence, and the need for further clinical evaluation.

show abstract

“…Regdanvimab is one of few anti-SARS-CoV-2 neutralizing mAbs that have received approval from either the FDA or EMA. Regdanvimab, administered by IV infusion at 40 mg/kg, provided a 72% reduction in risk of hospitalization and shortened the recovery time by ~ 5 days compared to placebo in its global Phase 3 clinical trial [31]. These results make regdanvimab a highly promising mAb for developing an inhaled COVID-19 therapy.…”

Section: Introductionmentioning

confidence: 99%

Stable nebulization and muco-trapping properties of Regdanvimab/IN-006 supports its development as a potent, dose-saving inhaled therapy for COVID-19

McSweeney

Stewart

Richardson

et al. 2022

Preprint

View full text Add to dashboard Cite

The respiratory tract represents the key target for antiviral delivery in early interventions to prevent severe COVID-19. While neutralizing monoclonal antibodies (mAb) possess considerable efficacy, their current reliance on parenteral dosing necessitates very large doses and places a substantial burden on the healthcare system. In contrast, direct inhaled delivery of mAb therapeutics offers the convenience of self-dosing at home, as well as much more efficient mAb delivery to the respiratory tract. Here, building on our previous discovery of Fc-mucin interactions crosslinking viruses to mucins, we showed that regdanvimab, a potent neutralizing mAb already approved for COVID-19 in several countries around the world, can effectively trap SARS-CoV-2 virus-like-particles in fresh human airway mucus. IN-006, a reformulation of Regdanvimab, was stably nebulized across a wide range of concentrations, with no loss of activity and no formation of aggregates. Finally, nebulized delivery of IN-006 resulted in 100-fold greater mAb levels in the lungs of rats compared to serum, in marked contrast to intravenously dosed mAbs. These results not only support our current efforts to evaluate the safety and efficacy of IN-006 in clinical trials, but more broadly substantiate nebulized delivery of human antiviral mAbs as a new paradigm in treating SARS-CoV-2 and other respiratory pathologies.

show abstract

Regdanvimab: First Approval

Cited by 47 publications

References 12 publications

Monoclonal antibody therapies in the management of SARS-CoV-2 infection

Monoclonal antibody therapies in the management of SARS-CoV-2 infection

SARS-CoV-2: Recent Variants and Clinical Efficacy of Antibody-Based Therapy

Stable nebulization and muco-trapping properties of Regdanvimab/IN-006 supports its development as a potent, dose-saving inhaled therapy for COVID-19

Contact Info

Product

Resources

About