Biologic License Application Omalizumab for the Treatment of Allergic Asthma Sponsor: Genentech

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Biologic License Application Omalizumab for the
Treatment of Allergic Asthma Sponsor Genentech

• Pulmonary - Allergy Drugs
• Advisory Committee Meeting
• May 15, 2003

Center for Biologics Evaluation and Research
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Omalizumab BLA Review Committee

• Patrick Swann, Ph.D.
• David Essayan, M.D.
• James Kaiser, M.D.
• Dwaine Rieves, M.D.
• Hong Zhao, Ph.D.
• M. David Green, Ph.D.
• Chao Wang, Ph.D.
• J. Lloyd Johnson, Pharm.D.
• Reginald Neal
• Dale Slavin, Ph.D.
• Karen Jones

• Chair and Product Review
• Clinical Review
• Pharmacology/Toxicology
• Review
• Statistical Review
• Bioresearch Monitoring
• Establishment Manufacturing
• Regulatory Management

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Omalizumab

• USAN Name
• Omalizumab
• Proposed Trade-name
• XolairTM
• Other Names
• E25
• rhuMAb-E25

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Omalizumab

• Recombinant Chinese Hamster Ovary cell-derived
  humanized IgG1k monoclonal antibody (m.w.
   149 kD)
• Binds circulating IgE regardless of IgE
  specificity
• Prevents binding of IgE to FceRI, the high
  affinity receptor for IgE, on mast cells and
  basophils

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Omalizumab

• Was designed not to bind cell-bound IgE and
  therefore should not activate mast cells or
  basophils
• Forms small omalizumab-IgE complexes that, in
  vitro, do not activate complement

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Omalizumab - Genentech

• A number of manufacturing issues remain to be
  resolved and related discussions are on-going
  with the sponsor.