Roche's rheumatoid arthritis candidate Actemra will undergo an evaluation by FDA's Arthritis Drugs Advisory Committee July 29.

The sponsor is seeking approval of Actemra (tocilizumab) both as a monotherapy and in combination with disease-altering antirheumatic drugs.

Tocilizumab would be the first interleukin-6 receptor inhibitor approved for treatment of moderately to severely active rheumatoid arthritis in adults, providing an alternative to anti-tumor necrosis factor inhibitors.

The BLA has a September user fee action date. Actemra, developed by Chugai, was approved for RA by Japanese regulators in April, and an application to market the product in the EU is pending.

-Brian Marson (b.marson @elsevier.com)

Roche’s Actemra Gets Advisory Committee Review

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