The China National Medical Products Administration (NMPA) has approved SYLVANT (siltuximab for injection) for the treatment of patients with multicentric Castleman disease (MCD), BeiGene Ltd. and EUSA Pharma Ltd today announced. MCD is known as a lymphoproliferative disorder, a very rare, but life-threatening condition that is characterized by enlargement of the lymph nodes, overgrowth of immune cells, and affecting lymphatic-associated tissues, often leading to poor patient outcomes and debilitating effects. As a drug, Siltuximab acts as a monoclonal antibody that neutralized IL-6, a pro-inflammatory cytokine that is primarily elevated in numerous inflammatory conditions. This approval decision, which follows similar decisions in the United States, European Union, and nations around the world, was based off a multinational, placebo-controlled study of Asian patients that measured both durable tumor and symptomatic response, along with review of the resolution or reduction of associated MCD symptoms without treatment failure. This partnership between EUSA Pharma and BeiGene is built on a shared commitment to developing medicines and therapeutics to address patients’ unmet needs in oncology and rare diseases. BeiGen and EUSA rely on this commitment and partnership to help advance clinical candidates that are effective, affordable, and accessible for a global patient population.
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