FDA Approves New Actemra SC Formulation
Genentech announced that the 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 >1 disease-modifying antirheumatic drug (DMARDs), such as methotrexate, that did not provide adequate relief.
The new SC formulation can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. Actemra is the first and only humanized interleukin-6 (IL-6) receptor-antagonist monoclonal antibody that is FDA-approved for both SC and IV administration.
This approval is based on data from the Phase III clinical trials SUMMACTA and BREVACTA.
Actemra is indicated to treat:
- Moderately-to-severely active RA in patients who have had an inadequate response to ≥1 DMARDs; may be used as monotherapy or concomitantly with methotrexate or other DMARDs
- Active systemic juvenile idiopathic arthritis (SJIA) as monotherapy, or in combination with methotrexate
- Active polyarticular juvenile idiopathic arthritis (PJIA) as monotherapy, or in combination with methotrexate
The new prefilled syringe injection formulation will be available in November 2013.
For more information call (800) 228-3672 or visit Actemra.com.