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Roche bags US FDA approval for new administration of children's arthritis drug

Roche Holding AG said the U.S. Food and Drug Administration approved a new way of administering its Actemra medicine to treat children aged 2 and older who have a specific type of arthritis.

Genentech Inc., a unit of Roche, said the U.S. regulator approved the subcutaneous formulation of Actemra, or tocilizumab, which is injected under the skin to treat active polyarticular juvenile idiopathic arthritis.

Polyarticular juvenile idiopathic arthritis is characterized by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.

The company said Actemra can be given alone or in combination with methotrexate, a chemotherapy agent and immune system suppressant.

The approval was based on data from a phase 1b study in children who were either intolerant or did not respond well to methotrexate and were receiving an intravenous formulation of Actemra with adequate disease control.

In 2013, the U.S. FDA approved the drug's intravenous version, which is administered into a vein to treat the disease.