BioCentury
ARTICLE | Product Development

Amgen’s adaptive solution to lupus

Amgen tackles clinical development challenges in lupus with an adaptive trial design

November 7, 2020 2:12 AM UTC

The latest study selected for FDA’s Complex Innovative Trial Designs pilot program aims to address one of the biggest problems in clinical development for systemic lupus erythematosus: translating Phase II signals to positive registrational data. 

Last week, Amgen Inc. (NASDAQ:AMGN) announced its adaptive Phase II trial of systemic lupus erythematosus therapy efavaleukin alfa (AMG 592) was accepted into the CID program — an FDA initiative designed to improve the efficiency of late-stage clinical development while promoting innovation with novel trial structures and statistical modeling. ...

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