Elan/Biogen Idec Antegren Multiple Sclerosis Filing Slated For Mid-Year
This article was originally published in The Pink Sheet Daily
Executive Summary
BLA filing decision announced after a meeting with FDA to discuss first year of data from Phase III studies on use of natalizumab as monotherapy and in combination.
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Antegren BLA Submission For Multiple Sclerosis Could See Approval By Year-End
Biogen Idec and Elan are requesting priority review for the MS submission. Companies are also seeking accelerated approval; BLA is based on one-year data from ongoing AFFIRM and SENTINEL trials.
Antegren BLA Submission For Multiple Sclerosis Could See Approval By Year-End
Biogen Idec and Elan are requesting priority review for the MS submission. Companies are also seeking accelerated approval; BLA is based on one-year data from ongoing AFFIRM and SENTINEL trials.
Monoclonal Antibodies for Inflammatory Bowel Disease Take Center Stage At Digestive Disease Week
Studies of Biogen Idec/Elan's Antegren, Abbott's Humira and Protein Design Labs' HuZAF for Crohn's disease were presented at the meeting. Presentations of non-MAb's included Otsuka's OPC-6535, Alizyme's renzapride and Solvay's cilansetron.