US orphan status for Pharmalink’s Busulipo
Swedish specialty pharma group Pharmalink says its product Busulipo, (busulfan), a best-in-class conditioning agent for use in cancer patients prior to hematopoietic stem cell transplantation (HSCT; also known as bone marrow transplantation), has received Orphan Drug designation from the US Food and Drug Administration.
The company is currently preparing for registration trials with an optimized formulation of Busulipo as part of its plans to advance the product towards the market. Busulipo has been developed by Pharmalink as a liposome/lipid complex formulation that improves the safety and stability of the chemotherapy agent busulfan, and is aimed at becoming the new gold standard for use in conditioning prior to HSCT. An early Busulipo formulation has successfully undergone clinical trials with more than 90 patients treated.
More patients expected to become eligible for HSCT
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