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Teplizumab - Provention Bio

Drug Profile

Teplizumab - Provention Bio

Alternative Names: hOKT3-gamma-1-ala-ala; hOKT3-γ1-ala-ala; MGA031; PRV 031

Latest Information Update: 31 Oct 2019

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At a glance

  • Originator Tolerance Therapeutics
  • Developer Immune Tolerance Network; MacroGenics; National Institute of Diabetes and Digestive and Kidney Diseases; National Institutes of Health (USA); Provention Bio
  • Class Antihyperglycaemics; Monoclonal antibodies
  • Mechanism of Action CD3 antigen inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Type 1 diabetes mellitus
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Type 1 diabetes mellitus
  • Discontinued Multiple sclerosis; Psoriasis; Psoriatic arthritis

Most Recent Events

  • 24 Oct 2019 Teplizumab receives Priority Medicine (PRIME) status for Type 1 diabetes mellitus (Prevention) in European Union
  • 24 Sep 2019 Provention Bio anticipates a meeting with the US FDA for discussions related to expedited development plan for teplizumab in Type 1 diabetes mellitus (Prevention) (IV), in the fourth quarter of 2019
  • 24 Sep 2019 Provention Bio intends to submit a BLA for Type 1 diabetes mellitus (Prevention) to the US FDA, in the fourth quarter of 2020 (IV)
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