FDA backs Janssen’s Sylvant for rare disease

The US Food and Drug Administration yesterday approved Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech’s Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).

Sylvant, for which a regulatory filings was made in the USA and Europe last summer (The Pharma Letter September 4, 2013), is an injection that works by blocking a protein that stimulates abnormal growth of immune cells. It is intended for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8).

First MCD agent Oked in USA