Siltuximab BLA Submitted for Rare Blood Disorder
Janssen R&D announced the submission of a Biologic License Application (BLA) to the FDA for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative. Siltuximab is an investigational, anti-interleukin-6 (IL-6) chimeric monoclonal antibody that targets and binds to human IL-6.
The siltuximab regulatory submissions include data from a randomized, multi-national, double-blind, placebo-controlled study (MCD2001) and data from two non-randomized supportive studies. The MCD2001 study assessed the efficacy and safety of siltuximab plus best supportive care (BSC) compared with placebo plus BSC in patients with MCD. In the study, 79 patients were randomized in a 2:1 ratio to one of the two treatment groups, with 53 receiving siltuximab and BSC, and 26 receiving placebo and BSC.
Siltuximab was previously granted orphan drug status for multicentric Castleman disease.For more information call (800) 526-7736 or visit Janssenrnd.com.