ERYtech Pharma: FDA Grants Orphan Drug Designation To GRASPA(R) For Treatment Of Acute Lymphoblastic Leukaemia

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology;  Blood / Hematology
Article Date: 27 Jan 2010 - 20:00 PDT

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ERYtech Pharma announces that FDA has granted an Orphan Drug Designation (ODD) for GRASPA®, the company's lead product in Acute Lymphoblastic Leukaemia.

Pierre-Olivier Goineau, Co-Founder and COO comments: ''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 United States market. It also confirms the similar evaluation of GRASPA as a medicinal product by both agencies."

"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 Pharma is now positioned to continue its expansion in the US" adds Doctor Yann Godfrin, Co-Founder and CEO of ERYtech Pharma.

GRASPA® is a new enzyme formulation of L-asparaginase with a safer and broader range of clinical use's compared to existing forms due to the enzymes entrapment and protection inside the homologous red blood cell. GRASPA®'s (encapsulating L-asparaginase in red blood cells) interest is to overcome all existing limitations associated with conventional L-asparaginase through a longer efficacy, better compliance, reduced dosage and an increased safety profile; making it satisfactory for every ALL patient, even high risk ones (hypersensitive, elderly patients), or patients with neutralising antibodies.

L-asparaginase is a critical and irreplaceable component of combination chemotherapy for ALL and has been used in the clinic for over 30 years. The enzyme depletes the plasmatic amino acid asparagine, which leukaemia cells require to continue their rapid, malignant growth. While normal cells are able to make a sufficient amount of asparagine internally, leukaemia cells cannot. Infusion of L-asparaginase destroys the external source of asparagine, which starves leukaemia cells of this amino acid and leads to cellular death.

Source
ERYtech Pharma

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