FDA approves subcutaneous Actemra for rheumatoid arthritis

New formulation approved for adults who have not responded sufficiently to methotrexate

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new formulation of a drug made by Genentech for rheumatoid arthritis that can be injected into the skin.

Genentech announced the approval of a subcutaneous formulation of Actemra (tocilizumab) in adults for adults with moderate RA who have not found sufficient relief by taking such disease-modifying antirheumatic drugs as methotrexate. Like the intravenous formulation of Actemra, the new version can be used alone or with drugs like methotrexate.

"People with moderately to severely active rheumatoid arthritis can suffer irreversible joint damage that may be prevented by earlier treatment with a medicine such as Actemra," Genentech chief medical officer and head of global product development Hal Barron said. "We're pleased that these patients will now have the option of Actemra as a subcutaneous injection or an IV infusion."


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