Amgen (NASDAQ:AMGN) announces that it has completed meetings with the FDA regarding the design of its Phase 2 clinical trial evaluating efavaleukin alfa (formerly AMG 592) for the potential treatment of systemic lupus erythematosus (SLE).
The study will be conducted under the agency's Complex Innovative Trials Designs (CID) Pilot Program aimed at modernizing drug development, improving efficiency and promoting innovation. Designs under the program include complex adaptive, Bayesian, and other novel clinical trial designs which often require simulations to determine the statistical properties of the trial. The FDA considers several eligibility factors when selecting qualifying programs, including the level of innovation of the trial design, and the therapeutic need.
Efavaleukin alfa is an IL-2 mutein Fc fusion protein, a cousin of interleukin-2, that exhibits cell-protective and anti-inflammatory effects.
https://seekingalpha.com/news/3626751-amgen-mid-stage-study-of-efavaleukin-alfa-for-lupus-part-of-fdas-innovative-trial-design
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