FDA approves SC formulation of Genentech's Actemra for rheumatoid arthritis

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) formulation of Actemra^® (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that 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.

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

Actemra, originally approved by the FDA as an IV medicine in 2010, is the first and only humanized interleukin-6 (IL-6) receptor-antagonist monoclonal antibody approved by the FDA for both SC and IV administration.

"Because some patients prefer a subcutaneous injection, it is important for physicians to have this new option," said Alan J. Kivitz, M.D., FACR, President of Altoona Center for Clinical Research, Duncansville, Pa. "In clinical trials, Actemra was shown to be effective and have a consistent safety profile - with the exception of injection site reactions for the subcutaneous formulation - when administered either intravenously or subcutaneously and may be used with or without methotrexate."

The approval is based on data from the Phase III clinical trials SUMMACTA and BREVACTA. For Actemra SC, the FDA recommended dosage is 162 mg administered subcutaneously every other week, followed by an increase to 162 mg every week based on clinical response for patients less than 100 kg (220 lbs) in weight. For patients at or above 100 kg (220 lbs), the dosing is 162 mg administered subcutaneously every week.