On Friday, Food and Drug Administration approved the use of Roche Holding AG's rheumatoid arthritis drug, Actemra to treat a rare type of arthritis in children.
The authority is trying to widen the use of drug Actemra and has thus approved its alone usage or combination usage with methotrexate in order to treat active systemic juvenile idiopathic arthritis in children aged between two years and older.
FDA has further cleared about SJIA, or Still's disease, which is basically a rarely found life-threatening disorder in children that can lead to severe inflammation throughout the body of the children. Also, FDA revealed that the mortality rate of SJIA is 2%-4% and the ailment has accounted for approx two-third of the total number of deaths among children due to arthritis.
In context to the same, Badrul Chowdhury, the Head of FDA's pulmonary, allergy, and rheumatology products division said that "This new indication of Actemra provides the first approved therapy for children with this rare disease".
It has been only a year since approval was given to the usage of Actemra to treat adults with moderately to severely active rheumatoid arthritis, who have had an inadequate response to other approved therapies.
The FDA approved for the usage of drug to treat SJIA because of the positive data that was cited in the late stage 'TENDER' study, according to which, 85% children with SJIA receiving Actemra experienced a 30% improvement in the signs and symptoms of SJIA.












