Program Goals Overview Natalizumab Natalizumab: Recent Label Changes.

Slides:

Advertisements

Similar presentations

Tysabri ® (natalizumab) Biogen Idec Inc. BLA /15 Peripheral and Central Nervous System Drugs Advisory Committee Gaithersburg, Maryland March 7-8,

Advertisements

Phase Difference = Phase Difference = 0.05.

By Matthew Sampson. Overview What is it? Previous Treatments Monoclonal Antibodies Chimeric Molecules Oral Therapies Hematopoietic Stem Cells Future.

MOnoclonal antibodies and potential applications in migraine

Copyright © 2009 American Medical Association. All rights reserved.

Introduction to Biosimilars

Highlights From the 2015 European Multiple Sclerosis Meeting

Applying Biosimilars in Hematologic Cancers

MS Highlights From the 2017 Annual Neurology Meeting

Improving the Diagnosis and Treatment of Seizures in Long-term Care

Program Goals Teriflunomide: Pooled Safety Data.

T-Cell Exhaustion: Can We Overcome It in Cancer?

Immune Reconstitution in MS:

Understanding Biologics

Charting Progress in MS Diagnosis and Treatment for Today and Tomorrow

Applying Real-World Evidence in MS: Reviewing the State of the Art

Clues to a Diagnosis: A Focus on Light-Chain Amyloidosis

Peripheral T-Cell Lymphoma in 2013

Emerging Data and Clinical Advances in MS:

Perspectives on Key MS Data From the Annual Neurology Meeting

T-Cell Directed Therapy in MS

Challenges in Managing Progressive Multiple Sclerosis

The Nurse View.

Oral vs IV High-Dose Methylprednisolone Are Equally Effective in MS

Are We Closer to Personalized Medicine in MS?

Pharmacist Perspectives on Novel Agents in Multiple Myeloma

CD30 and Lymphoma: Pathology in Practice

Practical Guidance on Using New Therapies for Relapsed/ Refractory Follicular Lymphoma and Chronic Lymphocytic Leukemia.

Evaluating Next-Generation BTK Inhibitors

Case Studies in Unresectable Hepatocellular Carcinoma

Navigating New Oral Treatment Algorithms in CLL

Program Goals Disclaimer Overview Assessing Disease Activity.

Ask the Experts.

Program Goals Overview Glatiramer Acetate 3 Times a Week.

Biosimilars in Hematologic Oncology

Charting Progress in MS Treatment:

Perspectives on the Impact of Inflammation in OA

Improving Therapeutic Management of Huntington's Disease in Long-Term Care.

Personalized Therapy in Relapsed or Refractory CLL

Advancing the Treatment of IBD With Biologics

What's New on Interventions for Lower Limb Spasticity?

Advances in Multiple Myeloma: Data Highlights and Analysis from the 2015 Hematology/Oncology Conferences.

Label Name Label Name Label Name Label Name Label Name Label Name

Cytokine-Release Syndrome in Patients With B-Cell Chronic Lymphocytic Leukemia and High Lymphocyte Counts After Treatment With an Anti-CD20 Monoclonal.

Figure 4 The molecular configuration of the CD20 molecule

Program Goals Overview Is NEDA a Reasonable Target?

Expert Perspectives on New Data in Multiple Sclerosis From the 2018 European MS Meeting.

Monoclonal Antibodies in CVD: What Does the Future Hold?

Clinical Pearls on Hot Topics in MS

This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the US, and data that were.

New European Anticoagulant Approvals Will They Affect Practical Guidance?

Program Goals Disclaimers Defining Refractory Seizures.

Program Goals. Program Goals LDL Established Target for Cardiovascular Risk.

Application of Biologics in IBD:

Patient and Clinician Perspectives on Preventive Therapy for Migraine

Emerging Multiple Sclerosis Therapies

Figure 2 JCV index JCV index (A) Fifty samples of natalizumab-treated patients with multiple sclerosis were assessed twice for their anti-JCV antibody.

Oral Treatment Strategies in CLL

Program Goals Overview Is NEDA a Reasonable Target?

Oral Therapies in MS.

Novel Therapeutics in MS

Pathogenesis of IBD, and the Role of Biologic Therapies

This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the US, and data that were.

Mitigating Infection Risk With DMT in MS

Behçet Syndrome (BS) Overview

The ABCs of Therapeutic Strategies in Pregnancy and Multiple Sclerosis

Updates in Progressive MS

Figure Simple schematic depicting the general effects of selected DMTs on lymphocytes Simple schematic depicting the general effects of selected DMTs on.

Monoclonal antibodies and fusion proteins and their complications: Targeting B cells in autoimmune diseases Susan Lee, MD, Mark Ballow, MD Journal of.

Foundations of Asthma.

Presentation transcript:

Program Goals

Overview

Natalizumab

Natalizumab: Recent Label Changes

Natalizumab: PML

Antibody Index

Antibody Index: Case Examples

Switching From Natalizumab

Switching From Natalizumab (cont)

Rituximab

Switching to an Oral Agent

On the Horizon: Anti-CD20 Agents: Ocrelizumab

On the Horizon: Anti-CD20 Agents: Ofatumumab

Rituximab Open-Label Phase 2 Study

Rituximab: Unresolved Issues

Alemtuzumab

The Monoclonal Pipeline: Daclizumab

Other Developments

Summary and Key Points

Abbreviations

References

References (cont)

References (cont)

References (cont)