BeiGene - EUSA Pharma's Siltuximab Approved In China For Multicentric Castleman Disease

The China National Medical Products Administration has approved BeiGene Ltd BGNEEUSA Pharma (UK) Ltd's Sylvant (siltuximab) for adult patients with multicentric Castleman disease (MCD), also known as idiopathic MCD (iMCD).

  • The approval covers patients who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative.
  • The disease is a condition of the lymph nodes and related tissues. The Company plans to launch the treatment in 2022.
  • Phase 2 trial results supported the approval of siltuximab. There was a statistically significant difference in independently reviewed durable tumor and symptomatic response rate in the siltuximab arm compared with the placebo arm (34% vs. 0%, respectively).
  • An open-label, long-term extension Phase 2 trial was also conducted. 
  • The median duration of siltuximab treatment was 5.52 years (range: 0.8 to 10.8 years); more than 50% of patients received siltuximab treatment for ≥5 years. 
  • The rate of severe adverse events did not increase over time due to cumulative exposure.
  • Siltuximab is a monoclonal antibody that directly neutralizes IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions.
  • Price Action: BGNE shares are up 0.04% at $346.01 during the premarket session on the last check Friday.
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