1 / 6

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

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. Patrick Swann, Ph.D. David Essayan, M.D. James Kaiser, M.D.

red
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

  2. 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 Omalizumab BLA Review Committee

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

  4. 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 Omalizumab

  5. 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 Omalizumab

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

More Related