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Genentech receives FDA approval of IL-6 receptor inhibitor for the treatment of systemic juvenile idiopathic arthritis
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Genentech announced in a press release that the FDA approved ACTEMRA (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
ACTEMRA can be given alone or in combination with methotrexate in patients with systemic juvenile idiopathic arthritis (SJIA), according to the release. 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, according to the Genentech press release.
“Today’s FDA approval marks an important advance in the treatment of SJIA, a debilitating condition affecting children,” Hal Barron, MD, chief medical officer and head Global Product Development, stated in the release. “As the first and only approved treatment for SJIA, ACTEMRA offers a new option for this extremely difficult to treat disease. This approval also demonstrates our commitment to science and patients with high unmet medical need, including orphan diseases."
“The goal of treatment for children with SJIA is to reduce the signs and symptoms of the disease, including swelling, pain and other complications,” Hermine Brunner, MD, MSc, associate professor of pediatric rheumatology, at 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, stated in the release. “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.”
According to the press release, the approval was based on positive data from a Phase III study known as TENDER. The results showed that 85% (64/75) of children with SJIA receiving ACTEMRA experienced a 30% improvement (JIA ACR30) in the signs and symptoms of SJIA and an absence of fever after 12 weeks of therapy, compared with 24% (9/37) of children receiving placebo (P<0.0001).