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Bezlotoxumab

Generic Name
Bezlotoxumab
Brand Names
Zinplava
Drug Type
Biotech
CAS Number
1246264-45-8
Unique Ingredient Identifier
4H5YMK1H2E

Overview

Bezlotoxumab is a fully humanized ImmunoglobulinG1 (IgG1) kappa monoclonal antibody that binds to Clostridium difficile toxin B and neutralizes its effects. First approved by the FDA on October 21, 2016, bezlotoxumab is used to reduce the recurrence of C. difficile infection. On November 22, 2016, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the granting of a marketing authorization. The drug was granted full approval by the EMA on January 18, 2017.

Background

Bezlotoxumab is a fully humanized ImmunoglobulinG1 (IgG1) kappa monoclonal antibody that binds to Clostridium difficile toxin B and neutralizes its effects. First approved by the FDA on October 21, 2016, bezlotoxumab is used to reduce the recurrence of C. difficile infection. On November 22, 2016, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the granting of a marketing authorization. The drug was granted full approval by the EMA on January 18, 2017.

Indication

Bezlotoxumab is indicated to reduce the recurrence of Clostridioides difficile infection (CDI) in patients who are receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence. In the US, the drug is approved for use in patients one year of age and older. In Europe, it is approved in adults only.

Associated Conditions

  • Clostridium difficile infection recurrence

FDA Approved Products

ZINPLAVA
Manufacturer:Merck Sharp & Dohme LLC
Route:INTRAVENOUS
Strength:25 mg in 1 mL
Approved: 2023/05/26
NDC:0006-3025

Singapore Approved Products

No Singapore products found for this drug

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