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By: Decision Resources Inc

In: The SAGE Handbook of Healthcare

Chapter 34: Future of VLA-4 Antagonist Drugs and Implications for the Regulatory Process

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Future of VLA-4 Antagonist Drugs and Implications for the Regulatory Process
Future of VLA-4 antagonist drugs and implications for the regulatory process
Introduction

Several companies have been investigating the potential of very late activation antigen-4 (VLA-4, also known as α4β1 integrin), located on the surface of T cells, as a drug target in a variety of inflammatory diseases. However, in March 2005, in response to difficulties with Biogen Idec and Elan's natalizumab (Tysabri, formerly Antegren) – a marketed monoclonal antibody (MAb) directed against this integrin – the FDA decided to place a clinical hold on another VLA-4 acting drug in clinical trials, and a second company voluntarily withdrew its VLA-4 drug from development while an investigation into the safety of this drug class is conducted. These safety ...

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