Roche has resubmitted Actemra, its potential blockbuster rheumatoid arthritis drug, to the US Food and Drug Administration.
The agency requested additional non-clinical data on Actemra (tocilizumab) in December last year, and the Swiss major says it “has worked diligently to fulfill the FDA’s requirements for Actemra and has submitted the complete response resubmission earlier than anticipated”. The resubmission includes a proposed risk evaluation and mitigation strategy and non-clinical studies evaluating the effect of Actemra on peri- and post-natal development and fertility.
Roche added that the FDA has designated a six-month review timeline for the resubmission of Actemra, the first interleukin-6 receptor-inhibiting monoclonal antibody for RA. In July last year, the FDA’s Arthritis Advisory Committee recommended approval of the drug in a 10-to-1 vote.
The Biologics License Application is based on studies of over 4,000 patients which demonstrated that the drug, alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs significantly reduced the signs and symptoms of RA, regardless of previous therapy or disease severity, compared to DMARDS alone.
Actemra was first approved in Japan and launched by Roche unit Chugai in June 2005 as a therapy for Castleman’s disease and then in April 2008 for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis. RoActemra was approved in the European Union in January this year and is also marketed in several other countries, including India, Brazil, Switzerland and Australia.
