MCD is a rare disorder that causes an abnormal overgrowth of immune cells in lymph nodes and related tissues.
Sylvant, marketed by Horsham, Pa.-based Janssen Biotech, is an injection that blocks a protein that stimulates the abnormal growth of immune cells.
In a clinical trial, 34 percent of participants who received Sylvant experienced tumor response, but no participant receiving a placebo experienced tumor response, according to an FDA news release.
The FDA reviewed Sylvant under priority review, an expedited review for drugs demonstrating potential to significantly improve safety and effectiveness in treatment of a serious condition. The FDA also granted Sylvant orphan product designation since it is intended to treat a rare disease or condition.
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