Genentech’s SC Actemra approved by US FDA for severe RA

Genentech, subsidiary of Swiss drug major Roche (ROG: SIX), has announced that the US Food and Drug Administration has approved a subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

The drug is for patients who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), which did not provide enough relief. Like the intravenous (IV) formulation, the SC formulation can be used both as a single-agent therapy and in combination with MTX or other non-biologic DMARDs. The Actemra pre-filled syringe (PFS) injection formulation will be available in November.

Hal Barron, chief medical officer and head, Global Product Development, said: “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. We're pleased that these patients will now have the option of Actemra as a subcutaneous injection or an IV infusion.”