European Medicines Agency: Advanced Therapeutic Classification granted to MB-107 slow virus gene therapy for the treatment of X chain of severe comprehensive immunodeficiency disease
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Last Update: 2020-05-29
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Source: Internet
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Author: User
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Mustang is a clinical biopharmaceutical company dedicated to the treatment of hematologic tumors, solid tumors and rare genetic diseases using cell and gene therapyRecently, the European Medicines Agency (EMA) has awarded mb-107 Advanced Therapy Classification (ATMP) for the treatment of the X chain of severe immunodeficiency disease (XSCID)The FDA previously awarded MB-107 Regenerative Medicine Advanced Therapy (RMAT) in August 2019 for the treatment of XSCIDATMP provides specific regulatory guidelines for preclinical development, manufacturing and product quality testing for MB-107, as kind as incentives, including reduced quality and non-clinical data evaluation and certification costs"We are very pleased that EMA has awarded the MB-107 Advanced Therapy Classification, which is an important step in Mustang's market recognition in Europe," said DrManuel Litchman, President and CEO of MustangX chain of severe comprehensive immunodeficiency patients urgently need innovative and potentially curable treatment options."
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