Posts Tagged Roche

Roche RA Drug Actemra Wins Support of US FDA Panel

Roche is happy to announce that its rheumatoid arthritis drug Actemra (tocilizumab) has won the recommending approval of the US FDA’s Arthritis Advisory Committee.

The committee’s vote was made after Roche presented results from five Phase III clinical trials. The clinical development program evaluated the effects of Actemra on signs and symptoms of RA, physical function, progression of structural damage, and health-related quality of life.

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Roche’s Arthritis Drug Actemra™ Got Japanese Approval

Roche Holding AG’s arthritis drug Actemra™ just won Japanese approval, which will then be sold by Roche’s Chugai unit.

Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of Actemra.

Four studies are completed and have reported meeting their primary endpoints. A fifth trial, a two-year study called LITHE (TociLIzumab safety and THE prevention of structural joint damage), is currently underway and is expected to report preliminary first-year data in 2008.

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