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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: 17 Dec 2019

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At a glance

  • Originator Genentech
  • Developer Dana-Farber Cancer Institute; Genentech; John Hopkins University; National Institute of Allergy and Infectious Diseases; Novartis
  • Class Antiallergics; Antiasthmatics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action 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
  • Registered Seasonal allergic rhinitis
  • Preregistration Nasal polyps
  • Phase III Food hypersensitivity; Peanut hypersensitivity
  • Phase II/III Mastocytosis
  • Phase II Asthma; Nephritis
  • No development reported Hypersensitivity

Most Recent Events

  • 12 Dec 2019 Registered for Seasonal allergic rhinitis (In adolescents, In children, In the elderly, Treatment-experienced, In adults) in Japan (SC)
  • 11 Dec 2019 Preregistration for Nasal polyps in USA (SC)
  • 11 Dec 2019 Novartis submits Type II variation to European Medicines Agency for Nasal Polyps
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