Enbrel Cleared For Ankylosing Spondylitis; Heart Failure Precaution Added
Executive Summary
Amgen/Wyeth is awaiting approval for two additional Enbrel indications following FDA clearance of the TNF-inhibitor for ankylosing spondylitis July 24
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Enbrel Ankylosing Spondylitis sBLA Clears FDA Cmte.; Modifying Claim Next
Sponsors seeking a disease-modifying claim for an ankylosing spondylitis indication should assess the radiographic progression of the disease, FDA's Arthritis Advisory Committee agreed during its June 24 review of Amgen/Wyeth's Enbrel