Roche receives U.S. FDA breakthrough therapy designation for ACTEMRA/RoACTEMRA in systemic sclerosis, and will present new study results at EULAR 2015

ACTEMRA/RoACTEMRA monotherapy and combination treatment regimens almost double sustained remission rates in people with early rheumatoid arthritis
Five year sustained efficacy of ACTEMRA/RoACTEMRA demonstrated in children with systemic juvenile idiopathic arthritis
Global Phase 3 clinical trial initiated in systemic sclerosis, a potentially fatal disease with limited treatment options

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) status to ACTEMRA®/RoACTEMRA® (tocilizumab) for systemic sclerosis (SSc).  This designation is designed to expedite the development and review of medicines intended to treat serious diseases, and to help ensure patients have access to them as soon as possible.  Roche also initiated a global Phase 3 study in SSc (NCT02453256).

In addition, new data from the U-ACT-EARLY and TENDER studies in patients with early rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sJIA), respectively, as well as results from the Phase 2 faSScinate study in SSc will be presented this week at the annual congress of the European League Against Rheumatism (EULAR 2015), Rome, 10 to 13 June.

"Close to 500,000 people worldwide have benefited from treatment with ACTEMRA/RoACTEMRA since initial approval over a decade ago.  The breadth of our study results at EULAR, ranging from arthritis in adults and children to a rare inflammatory disorder, underscores our commitment to helping people with debilitating autoimmune diseases," said Sandra Horning, M.D., Roche's Head of Global Product Development and Chief Medical Officer.  "These new data further demonstrate the efficacy and safety of ACTEMRA/RoACTEMRA in multiple diseases, including use as a single therapy in early RA."


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