The China National Medical Products Administration has approved BeiGene Ltd (NASDAQ:BGNE) / EUSA 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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