Regdanvimab

Last updated

Regdanvimab
Monoclonal antibody
Type Whole antibody
Source Human
Target Spike protein of SARS-CoV-2
Clinical data
Trade names Regkirona
Other namesCT-P59
License data
Pregnancy
category
Routes of
administration
Intravenous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only) [2] [3]
  • EU:Rx-only [4] [5]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
UNII
KEGG

Regdanvimab, sold under the brand name Regkirona, is a human monoclonal antibody used for the treatment of COVID-19. [4] The antibody is directed against the spike protein of SARS-CoV-2. It is developed by Celltrion. [6] [7] The medicine is given by infusion (drip) into a vein. [4] [8]

Contents

The most common side effects include infusion-related reactions, including allergic reactions and anaphylaxis. [4]

Regdanvimab was approved for medical use in the European Union in November 2021. [4] [5]

Medical uses

In the European Union, regdanvimab is indicated for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. [4]

Society and culture

In March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of data on regdanvimab. [9] [10] In October 2021, the EMA started evaluating an application for marketing authorization for the monoclonal antibody regdanvimab (Regkirona) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19. [11] The applicant is Celltrion Healthcare Hungary Kft. [11] The European Medicines Agency (EMA) concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adults who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19. [8]

In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting a marketing authorization in the European Union for regdanvimab (Regkirona) for the treatment of COVID-19. [12] [13] The company that applied for authorization of Regkirona is Celltrion Healthcare Hungary Kft. [13] Regdanvimab was approved for medical use in the European Union in November 2021. [4] [5]

Names

Regdanvimab is the international nonproprietary name (INN). [14]

Related Research Articles

Adalimumab, sold under the brand name Humira, among others, is a monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. It is administered by subcutaneous injection.

<span class="mw-page-title-main">Tremelimumab</span>

Tremelimumab, sold under the brand name Imjudo, is a fully human monoclonal antibody used for the treatment of hepatocellular carcinoma. Tremelimumab is designed to attach to and block CTLA-4, a protein that controls the activity of T cells, which are part of the immune system.

Anifrolumab, sold under the brand name Saphnelo, is a monoclonal antibody used for the treatment of systemic lupus erythematosus (SLE). It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-α and interferon-β.

Celltrion, Inc. is a biopharmaceutical company headquartered in Incheon, South Korea. Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion. Celltrion's founder, Seo Jung-jin, is the richest person in South Korea.

Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker.

Eptinezumab, sold under the brand name Vyepti, is a medication used for the preventive treatment of migraine in adults. It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta. It is administered by intravenous infusion.

Ravulizumab, sold under the brand name Ultomiris, is a humanized monoclonal antibody complement inhibitor medication designed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome. It is designed to bind to and prevent the activation of Complement component 5 (C5).

Sutimlimab, sold under the brand name Enjaymo, is a monoclonal antibody that is used to treat adults with cold agglutinin disease (CAD). It is given by intravenous infusion. Sutimlimab prevents complement-enhanced activation of autoimmune human B cells in vitro.

<span class="mw-page-title-main">Trastuzumab deruxtecan</span> Medication

Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the topoisomerase I inhibitor deruxtecan. It is licensed for the treatment of breast cancer or gastric or gastroesophageal adenocarcinoma. Trastuzumab binds to and blocks signaling through epidermal growth factor receptor 2 (HER2/neu) on cancers that rely on it for growth. Additionally, once bound to HER2 receptors, the antibody is internalized by the cell, carrying the bound deruxtecan along with it, where it interferes with the cell's ability to make DNA structural changes and replicate its DNA during cell division, leading to DNA damage when the cell attempts to replicate itself, destroying the cell.

<span class="mw-page-title-main">COVID-19 drug development</span> Preventative and therapeutic medications for COVID-19 infection

COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research, with 419 potential COVID-19 drugs in clinical trials, as of April 2021.

<span class="mw-page-title-main">Pemigatinib</span> Pharmaceutical drug

Pemigatinib, sold under the brand name Pemazyre, is an anti-cancer medication used for the treatment of bile duct cancer (cholangiocarcinoma). Pemigatinib works by blocking FGFR2 in tumor cells to prevent them from growing and spreading.

Indacaterol/glycopyrronium bromide/mometasone, sold under the brand name Enerzair Breezhaler among others, is an inhalable fixed-dose combination medication for the treatment of asthma. It contains indacaterol as acetate, glycopyrronium bromide, and mometasone furoate.

<span class="mw-page-title-main">Casirivimab/imdevimab</span> Antiviral combination medication

Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, is a combination medicine used for the treatment and prevention of COVID‑19. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product. It was developed by the American biotechnology company Regeneron Pharmaceuticals.

Bamlanivimab is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19. The medication was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, and the EUA was revoked in April 2021.

Bamlanivimab/etesevimab is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together via intravenous infusion as a treatment for COVID-19. Both types of antibody target the surface spike protein of SARS‑CoV‑2.

<span class="mw-page-title-main">Sotrovimab</span> Monoclonal antibody

Sotrovimab, sold under the brand name Xevudy, is a human neutralizing monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2. It was developed by GlaxoSmithKline and Vir Biotechnology, Inc. Sotrovimab is designed to attach to the spike protein of SARS-CoV-2.

<span class="mw-page-title-main">Tixagevimab/cilgavimab</span> Monoclonal antibody treatment for COVID-19

Tixagevimab/cilgavimab, sold under the brand name Evusheld, is a combination of two human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2 used to prevent COVID-19. It is being developed by British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca. It is co-packaged and given as two separate consecutive intramuscular injections.

Ciltacabtagene autoleucel, sold under the brand name Carvykti, is an anti-cancer medication used to treat multiple myeloma. Ciltacabtagene autoleucel is a BCMA -directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using the recipient's own T-cells, which are collected and genetically modified, and infused back into the recipient.

Nivolumab/relatlimab, sold under the brand name Opdualag, is a fixed-dose combination medication use to treat melanoma. It contains nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody. It is given by intravenous infusion.

Teclistamab, sold under the brand name Tecvayli, is a human bispecific monoclonal antibody used for the treatment of relapsed and refractory multiple myeloma. It is a bispecific antibody that targets the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells.

References

  1. "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
  2. "AusPAR: Regdanvimab". Therapeutic Goods Administration (TGA). 7 December 2021. Archived from the original on 5 January 2022. Retrieved 4 January 2022.
  3. "TGA Provisional Approval of Celltrion Healthcare Australia Pty Ltd COVID-19 treatment, regdanvimab (Regkirona)". Therapeutic Goods Administration (TGA) (Press release). 6 December 2021. Archived from the original on 5 January 2022. Retrieved 4 January 2022.
  4. 1 2 3 4 5 6 7 "Regkirona EPAR". European Medicines Agency. 10 November 2021. Archived from the original on 12 November 2021. Retrieved 12 November 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. 1 2 3 "Regkirona". Union Register of medicinal products. 12 November 2021. Archived from the original on 24 April 2022. Retrieved 24 April 2022.
  6. "Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread Using Its Antibody Development Platform" (Press release). Celltrion. 11 February 2021. Archived from the original on 19 October 2021. Retrieved 4 March 2021 via Business Wire.
  7. "Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59" (Press release). Celltrion. 13 January 2021. Archived from the original on 19 October 2021. Retrieved 4 March 2021 via Business Wire.
  8. 1 2 "EMA issues advice on use of regdanvimab for treating COVID-19". European Medicines Agency. 26 March 2021. Archived from the original on 15 November 2021. Retrieved 15 October 2021.
  9. "EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19" (Press release). European Medicines Agency (EMA). 24 February 2021. Archived from the original on 15 November 2021. Retrieved 4 March 2021.
  10. "EMA review of regdanvimab for COVID-19 to support national decisions on early use" (Press release). European Medicines Agency (EMA). 2 March 2021. Archived from the original on 28 October 2021. Retrieved 4 March 2021.
  11. 1 2 "EMA receives application for marketing authorisation Regkirona (regdanvimab) treating patients with COVID-19". European Medicines Agency. 4 October 2021. Archived from the original on 11 November 2021. Retrieved 15 October 2021.
  12. "Regkirona: Pending EC decision". European Medicines Agency. 11 November 2021. Archived from the original on 11 November 2021. Retrieved 11 November 2021.
  13. 1 2 "COVID-19: EMA recommends authorisation of two monoclonal antibody medicines". European Medicines Agency (EMA) (Press release). 11 November 2021. Archived from the original on 13 November 2021. Retrieved 11 November 2021.
  14. World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85" (PDF). WHO Drug Information. 35 (1). Archived (PDF) from the original on 19 April 2021. Retrieved 24 April 2022.

Further reading