Pharmaprojects R&D Pipeline News Feed
Roche gets EU green light for tocilizumab
3 Feb 2009
Roche has received EU approval for RoActemra
(tocilizumab), its first-in-class therapy for the treatment
of adult patients with moderate-to-severe rheumatoid
arthritis (RA). This follows earlier approvals for the
product, known as Actemra outside of the EU, in Japan,
India and Switzerland, and is based on positive results
from five Phase III studies, in which treatment with Ro-
Actemra significantly reduced the symptoms of RA
when used alone or in combination with methotrexate
or other disease modifying anti-rheumatic drugs
(DMARDs), compared with current DMARDs alone.
RoActemra is the first humanised monoclonal antibody targeted against interleukin-6 for the treatment of RA. Interleukin-6 has been identified as having a major role in the inflammation process of the disease that is associated with intense pain, irreversible joint destruction and systemic complications.
Roche has a proven history in this area, having previously launched MabThera (rituximab), the first and only therapy targeting B-cells, which play an important role in the pathogenesis of RA; Phase III development of orcelizumab, a humanised anti-CD20 antibody, is also underway, again for the treatment of RA.
