Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA (tocilizumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older. ACTEMRA can be given alone or in combination with methotrexate in patients with SJIA.
ACTEMRA is the first medicine approved by the FDA for the treatment of SJIA, a rare and severe form of arthritis affecting children. SJIA has the worst long-term prognosis of all types of childhood arthritis.
“The goal of treatment for children with SJIA is to reduce the signs and symptoms of the disease, including swelling, pain and other complications,” said Hermine Brunner, PhD, MSc, associate professor of pediatric rheumatology, University of Cincinnati College of Medicine, Cincinnati Children’s Hospital Medical Center, scientific director of the pediatric rheumatology collaborative study group, and a study investigator. “We’re excited about the results of this study which show that ACTEMRA significantly improved disease signs and symptoms as measured by a JIA ACR response, plus absence of fever, a critical validated efficacy measure of SJIA treatment.”
This approval was based on positive data from a Phase III study known as TENDER. The results showed that 85 percent (64/75) of children with SJIA receiving ACTEMRA experienced a 30 percent improvement (JIA ACR30) in the signs and symptoms of SJIA and an absence of fever after 12 weeks of therapy, compared with 24 percent (9/37) of children receiving placebo.
Release Date: April 15, 2011
Filed Under: Drug Discovery