FDA approves new drug to treat juvenile idiopathic arthritis

On Friday, Food and Drug Administration approved the use of Roche Holding AG’s rheumatoid arthritis drug, Actemra to treat juvenile idiopathic arthritis in children.

The approval places Actemra as the first drug approved by the FDA for treating Systemic Juvenile Idiopathic Arthritis, or SJIA – a rare and severe form of arthritis affecting children.

According to the company, the approval was based on positive data from a Phase III study known as TENDER. The results showed that 85 percent of children with juvenile idiopathic arthritis receiving ACTEMRA experienced a 30 percent improvement in the signs and symptoms of juvenile idiopathic arthritisr and an absence of fever after 12 weeks of therapy, compared with 24 percent of children receiving placebo.

The FDA also notes that changes in liver enzymes, blood counts, and cholesterol are not uncommon with Actemra and should be monitored with regular blood tests.

The most common side effects in trial participants with juvenile idiopathic arthritisr included upper respiratory tract infection, headache, sore throat, and diarrhea.

Juvenile idiopathic arthritis is the rarest form of Juvenile Arthritis, also known as Juvenile Rheumatoid Arthritis (JRA). The disease affects about 10 to 20 percent of children with juvenile arthritis, with the peak age of onset between 18 months and two years. Although the disease can persist into adulthood. Juvenile idiopathic arthritis has a two to four percent overall estimated mortality rate, and accounts for almost two-thirds of all deaths among children with arthritis.