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Marketing Authorization Application (MAA) for etranacogene dezaparvovec will be reviewed under accelerated assessment and has the potential to be the first gene therapy for patients living with hemophilia B
MAA filing is supported by the phase 3 HOPE-B study which demonstrated durable and sustained therapeutic effect after a single infusion
Milestone underscores CSL Behring's promise to develop and deliver a truly unique portfolio of patient-focused therapies
MARBURG, Germany, March 28, 2022 ...
>>> Read more: European Medicines Agency Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B
MAA filing is supported by the phase 3 HOPE-B study which demonstrated durable and sustained therapeutic effect after a single infusion
Milestone underscores CSL Behring's promise to develop and deliver a truly unique portfolio of patient-focused therapies
MARBURG, Germany, March 28, 2022 ...
>>> Read more: European Medicines Agency Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B
