According to a story from Yahoo! Finance, EUSA Pharma Limited and BeiGene, Ltd. have recently announced that their Biologics License Application (BLA) has been accepted by the China National Medical Products Administration (NMPA). This application was accepted with priority review and pertains to the drug siltuximab (marketed as SYLVANT®), which is approved in the EU and US as a treatment for idiopathic multicentric Castleman disease, a rare disease.
About Castleman Disease
Castleman disease causes a variety of life-threatening symptoms and is characterized by an excessive production of lymphocytes, a type of white blood cell. Idiopathic multicentric Castleman disease is the most severe type. The precise cause is still not entirely clear, but it is most likely that the immune system plays a significant role. Symptoms are severe and varied, including enlarged lymph nodes, fatigue, night sweats, weight loss, fever, enlargement of the liver and/or spleen, fluid accumulation, shortness of breath, coughing, and dysfunction of vital organs, like the liver, bone marrow, and kidneys. Treatment includes siltuximab (the only FDA approved treatment), chemotherapy, surgery, corticosteroids, and immunosuppressants. To learn more about Castleman disease, click here.
SYLVANT is specifically approved for adult patients who are HIV negative and human herpesvirus-8 (HHV-8) negative. The drug is approved for Castleman disease is 40 countries around the world; the acceptance of the BLA is a major development for patients in China that have been living with the disease and have no access to an officially approved therapy.
SYLVANT is classified as a monoclonal antibody that acts on IL-6. This is an inflammatory cytokine that is often found to be elevated in a diverse array of inflammatory disease states. It has been investigated as a treatment for certain cancers and was approved for use in Castleman disease in 2014.
Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene, responded with excitement. He stated that this approval is positive news for Chinese patients with the rare condition.
Lee Morley, CEO at EUSA Pharma, said:
“We will continue in our close collaboration with BeiGene and the NMPA to potentially bring siltuximab to iMCD patients in China.”