Genentech, a member of the Roche Group (RO.SW, ROG.SW, RHHBY.PK), Tuesday said the U.S. Food and Drug Administration, or FDA, has approved ACTEMRA for the treatment of polyarticular juvenile idiopathic arthritis.
The rare, debilitating condition in children is characterized by inflammation in five or more joints, most commonly small joints such as the hands and feet, within the first six months of the disease.
The approval of ACTEMRA was backed by data from the Phase III CHERISH study which included a open label phase, followed by a randomized double-blind placebo-controlled withdrawal phase.
In the study, patients treated with ACTEMRA showed clinically meaningful improvement in signs and symptoms of the disease. A total of 91 percent of patients taking ACTEMRA with methotrexat and 83 percent of patients taking ACTEMRA alone achieved an ACR 30 response at week 16 compared to baseline.
Meanwhile, in the randomized double-blind placebo-controlled withdrawal phase of the trial, ACTEMRA-treated patients experienced significantly fewer disease flares compared to placebo-treated patients.
Infections were the most common adverse events observed over a period of 40 weeks. Laboratory abnormalities known to occur with ACTEMRA were also observed in this study, including decreases in white blood cell counts and platelet counts.
The medicine can can be given to children, two years of age and older, alone or in combination with methotrexat.
The FDA approval marks the second ACTEMRA indication in children and is the first FDA approval for the treatment of juvenile idiopathic arthritis in approximately five years.
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