FDA approves subcutaneous formulation of Actemra (Genentech/Roche)

The FDA has on 21 October 2013, approved a subcutaneous (SC) formulation of Actemra (tocilizumab) from Genentech/Roche 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.The approval is based on data from the Phase III clinical trials SUMMACTA and BREVACTA.