Sylvant siltuximab regulatory update

EMA's CHMP backed approval of an MAA from Johnson & Johnson's Janssen R&D LLC subsidiary for Sylvant siltuximab to treat multicentric Castleman's disease (MCD) in patients who are HIV-negative and human herpes virus 8 (HHV-8)-negative. Siltuximab is under accelerated assessment in the EU, which shortens the review period to 150 days from 210. A BLA for the chimeric mAb against IL-6 is also under Priority Review in the U.S., with a decision expected this half. The PDUFA date is undisclosed. A named patient program is available for siltuximab in the U.S. ...