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news.The FDA has granted Orphan Drug Designation (ODD) to ERYtech Pharma (ERYtech) for Graspa, the company’s lead product in Acute Lymphoblastic Leukaemia.
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Graspa is a new enzyme formulation of L-asparaginase with a safer and broader range of clinical use’s, as compared to existing forms, due to the enzymes entrapment and protection inside the homologous red blood cell.
Pierre-Olivier Goineau, co-founder and COO of ERYtech, said: ‘‘Following the ODD granted by EMEA for the use of Graspa for ALL in Europe, this ODD granted by FDA extends additional potential exclusivity to the US market. It also confirms the similar evaluation of Graspa as a medicinal product by both agencies.”
Yann Godfrin, co-founder and CEO of ERYtech, said: “Discussions are ongoing with US Key Opinion Leaders to initiate new clinical trials with Graspa. This ODD is the first achievement of our US strategy in 2010. As such, ERYtech is now positioned to continue its expansion in the US.”