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Global Blood Therapeutics Receives EMA PRIME Designation for GBT440 for the Treatment of Sickle Cell Disease (SCD)
GBT440 is First Potential Treatment for SCD To Be Accepted for PRIME.
PRIME Designation Allows for Frequent and Early Interactions with the Agency Aimed at Assisting Accelerated Evaluation and ApprovalF.
Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT) today announced that the European Medicines Agency (EMA) has determined that GBT440 for the treatment of sickle cell disease is eligible for its Priority Medicines (PRIME) program. The PRIME program is a new regulatory mechanism that provides for early and proactive EMA support to medicine developers to help patients benefit as early as possible from innovative new products that have demonstrated the potential to significantly address an unmet medical need.
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This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.