teplizumab (Tzield)

Introduction

• Sanofi has asked that teplizumab (Tzield) be pulled from the FDA, the Commissioner's National Priority Voucher (CNPV) program after Tracy Beth Hoeg, MD,PhD director of the FDA's Center for Drug Evaluation and Research overturned a staff decision to approve the treatment

Indications

• indicated to delay the progression of diabetes mellitus type 1
• approved for adults & pediatric patients >= 1 year with stage 2 type 1 diabetes to delay onset of stage 3, the irreversible stage when insulin-producing beta-cells lose ability to maintain normal glycemic control

Dosage

• premedicate & treat symptoms with antipyretics, antihistamines, &/or antiemetics

Adverse effects

• most common
  • lymphopenia, rash, leukopenia, headache
• hepatotoxicity
• warning of cytokine release syndrome

Mechanism of action

• anti-CD3 monoclonal antibody
• believed to work by deactivating immune cells that attack insulin-producing beta-cells, while increasing the proportion of cells that help moderate the immune response
• may delay clinical diagnosis of type 1 diabetes by months to years

More general terms

• endocrine agent
• monoclonal antibody