Arthritis Development Strategy: Cimzia’s BLA Has More Wiggle Room, But Humira Uses Tougher Endpoint

Heading into a July 23 Arthritis Advisory Committee, AbbVie’s Humira brings a robust efficacy showing but also total reliance on a new patient diagnostic mechanism; the product’s supplemental application will be reviewed alongside a similar one for UCB’s Cimzia.

UCB Group’s broad indication for its anti-tumor necrosis factor Cimzia for active axial spondyloarthritis (axSpA) may give it an edge over competitor AbbVie Inc.’s Humira as the two companies prepare for July 23 advisory committee reviews. However, AbbVie could benefit from using a tougher endpoint in its pivotal trial.

The Arthritis Advisory Committee reviews will come a day after the committee discusses the implications of using new classification criteria...

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