Fibrocell Science, Inc. (Nasdaq: FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to FCX-007, the Companys gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB)a devastating, genetic skin disease with high mortality.
Created under the 21st Century Cures Act, RMAT offers sponsors of cell and gene therapies eligibility for accelerated development and review of their product if it is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence showing it has the potential to address unmet medical needs. This designation makes a product eligible for the same actions to expedite the development and review of a marketing application that are available to drugs that receive Breakthrough Therapy designation, including earlier and more frequent meetings with the FDA and potential eligibility for Priority Review and Accelerated Approval.
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