Janssen’s MCD drug SYLVANT gets FDA approval

The drug was not evaluated in patients with MCD who are HIV positive or HHV-8 positive because it did not bind to virally produced interleukin-6 (IL-6) in a nonclinical study.

SYLVANT, which is an IL-6 antagonist biologic therapy administered as an intravenous (IV) infusion once every three weeks, is the first approved treatment for MCD in the US.

MCD is a rare blood disorder with high morbidity in which lymphocytes, a type of white blood cell, are over-produced, which leads to enlarged lymph nodes.

It can also affect lymphoid tissue of internal organs, causing the liver, spleen or other organs to enlarge.

University of Arkansas for Medical Sciences professor of Medicine, director of Developmental and Translational Medicine and MCD2001 study lead investigator Frits van Rhee said there has been a serious need for treatment options for patients with MCD.

"MCD is a complex disease and up until this point, physicians have tried to reduce lymph node masses and put the disease in remission through a combination of treatments, but MCD often returns," van Rhee said.

"Today’s approval of SYLVANT gives physicians a long-awaited treatment option for a group of patients who has been suffering with this chronic, serious and debilitating disease."

The efficacy and safety of SYLVANT were assessed in a multi-national, randomized, double-blind, placebo-controlled pivotal trial carried out in 79 patients with MCD.

In this trial about 53 patients were randomized to the SYLVANT arm at a dose of 11 mg/kg and 26 patients were randomized to the placebo arm.

Image: SYLVANT 100 and 400 mg Vials. Photo: courtesy of PRNewsFoto/Janssen Biotech