J&J provides siltuximab regulatory update, reports Phase II data

Johnson & Johnson (NYSE:JNJ) disclosed that FDA accepted and granted Priority Review to a BLA for siltuximab ( CNTO 328) to treat multicentric Castleman's disease (MCD) in patients who are HIV-negative and human herpes virus 8 (HHV-8)-negative. The PDUFA date is not disclosed. An MAA is also under accelerated assessment by EMA for the indication. The pharma submitted the applications in September. Multicentric Castleman's disease is a rare type of Castleman's disease that affects more than one group of lymph nodes in different anatomical areas. Castleman's disease is a B cell proliferative disorder that is not malignant but is nonetheless fatal because of systemic inflammation. ...