Popular rheumatoid arthritis drug claims it's not just for adult conditions.
The company has submitted a supplemental Biologics License Application (sBLA) to the FDA and an Accelerated Assessment application to the European Medicines Agency (EMA) to extend the license indication of the product.
sJIA is characterised by inflammatory arthritis accompanied by intermittent fever, skin rash, anemia, enlargement of the liver and/or spleen, and inflammation of the lining of the heart and/or lungs. The peak age of onset is between 18 months and two years, although persistence of the disease into adulthood occurs. sJIA has the worst long-term prognosis of all childhood arthritis subtypes, accounting for almost two-thirds of all deaths among children with arthritis, with an overall mortality rate estimated to be between 2-4%.
Current treatment consists of high dose corticosteroids, which do not improve the long-term prognosis and are often accompanied by severe side effects.
In a global phase III TENDER study, Actemra was found to be effective in improving the signs and symptoms of sJIA. The study was presented at the European League Against Rheumatism (EULAR) congress. The results demonstrated that, following three months’ treatment with Actemra, 85% of patients had a 30% improvement (JIA ACR302) in the signs and symptoms of sJIA and absence of fever, a primary characteristic of sJIA, compared to 24% of patients who received placebo. In addition to the significant improvement in JIA ACR response, nearly two-thirds of patients in the study were free of rash after three months. In the study, Actemra was well tolerated in children with sJIA with a safety profile similar to adults treated with the drug for rheumatoid arthritis (RA).
“sJIA is an extremely debilitating disease that can be life-threatening for young children, for which there are no currently approved medicines”, said Hal Barron, M.D, Head of Global Development and Chief Medical Officer for Roche, in a press release. “With these striking data we hope ACTEMRA may become a treatment option that benefits children and their families living with this condition every day.”
Have you been using Actemra as a treatment for Rheumatoid Arthritis? Will you be following the application process closely to see the results?