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Omalizumab - Genentech/Novartis

Drug Profile

Omalizumab - Genentech/Novartis

Alternative Names: Anti-IgE monoclonal antibody E25; E 25; IgE 025; Monoclonal antibody E25; Olizumab; Recombinant human monoclonal antibody E25; RG-3648; rhuMAb 25; rhuMAb E25; Xolair

Latest Information Update: 21 Dec 2018

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At a glance

  • Originator Genentech
  • Developer Dana-Farber Cancer Institute; Genentech; John Hopkins University; Novartis
  • Class Antiallergics; Antiasthmatics; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; IgE receptor antagonists; Immunosuppressants
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Allergic asthma; Urticaria
  • Phase III Nasal polyps; Seasonal allergic rhinitis
  • Phase II/III Mastocytosis
  • Phase II Asthma; Nephritis
  • No development reported Hypersensitivity; Peanut hypersensitivity

Most Recent Events

  • 13 Dec 2018 European Commission approves omalizumab prefilled syringe for self administration for Asthma and Urticaria
  • 20 Oct 2018 Novartis completes a phase III trial in Seasonal allergic rhinitis (In children, In adolescents, In adults, Treatment-experienced, In the elderly) in Japan (SC) (NCT03369704)
  • 03 Oct 2018 The US FDA approves omalizumab 75 mg/0.5 mL and 150 mg/1 mL single-dose pre-filled syringes for Allergic asthma and Urticaria
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