The FINANCIAl — Medicine offers a new option for children living with a rare and severe form of arthritis.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (U.S.) Food and Drug Administration (FDA) approved Actemra 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 (tocilizumab, known as RoActemra in the European Union) 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 company informed.
“Today’s FDA approval marks an important advance in the treatment of SJIA, a debilitating condition affecting children,” said Hal Barron, M.D., Chief Medical Officer and Head Global Product Development. “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."
SJIA is the rarest form of Juvenile Idiopathic Arthritis (JIA), also known as Juvenile Rheumatoid Arthritis (JRA).The disease affects about 10 to 20 percent of children with JIA2, with the peak age of onset between 18 months and two years,2,3 although the disease can persist into adulthood. SJIA has a two to four percent overall estimated mortality rate, and accounts for almost two-thirds of all deaths among children with arthritis4. The severity of SJIA varies from person to person and can include symptoms ranging from joint inflammation accompanied by intermittent fever, skin rash, anaemia, enlargement of the liver or spleen and inflammation of the lining of the heart and/or lungs5. In the most severe cases of SJIA, up to two-thirds of children experience chronic arthritis, and approximately half of children will develop significant joint disabilities6,7.
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