ARTICLE | Clinical News

Sylvant siltuximab regulatory update

April 28, 2014 7:00 AM UTC

FDA approved a BLA for Sylvant siltuximab from Johnson & Johnson's Janssen Biotech Inc. unit to treat multicentric Castleman's disease (MCD) in patients who are HIV-negative and human herpes virus 8 (HHV-8)-negative. The chimeric mAb against IL-6 is the first approved treatment in the U.S. for the disease, a rare blood disorder that affects groups of lymph nodes in different anatomical areas. Castleman's disease is a B cell proliferative disorder that is not malignant but is chronically debilitating and potentially fatal because of systemic inflammation. Sylvant has been available in the U.S. under a named-patient program, and J&J said it will formally launch the drug in the U.S. in a few weeks. The wholesale acquisition cost (WAC) for a 100 mg vial is $833. Sylvant is dosed at 11 mg/kg every 3 weeks until treatment failure, which translates to an annual WAC of $127,449 for a 75 kg person. ...