EU says yes to Roche drug
EU approves a first in class therapy for treatment of patients with moderate to severe form of rheumatoid arthritis.
with methotrexate, is indicated for the treatment of adult patients with moderate to severe rheumatoid arthritis who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs or tumour necrosis factor antagonists.
In these patients, Roactemra can be given as monotherapy in cases of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate. Roactemra is the first interleukin-6 receptorinhibiting monoclonal antibody developed for the treatment of rheumatoid arthritis and is a novel approach to help tackle this debilitating disease.
Rheumatoid arthritis is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications such as fatigue and anemia.
There are several key cytokines, or proteins, involved in the inflammatory process including tumor necrosis factor alpha, interleukin-1 and interleukin-6. IL-6 has been identified as having a pivotal role in the inflammation process. The exact cause of rheumatoid arthritis is unknown and there is no cure currently available.
The European Commission’s approval for Roactemra was based on results from the largest clinical program undertaken by a biologic in rheumatoid arthritis including, five multi-national phase III studies which demonstrated that treatment with Roactemra.
The approval in the EU follows earlier approvals for the product in several countries, including Japan, India and Switzerland.