Atara Biotherapeutics, Inc. announced that ATA230 was granted orphan drug designation for the treatment of cytomegalovirus (CMV) viremia and disease in immunocompromised patients by the U.S. Food and Drug Administration (FDA).
ATA230, an allogeneic T-cell immunotherapy targeting antigens expressed by CMV, has been investigated in one Phase 1 and two Phase 2 clinical studies in patients with CMV viremia and disease who are refractory or resistant to antiviral drug treatment.
“We are delighted that the therapeutic potential of our allogeneic T-cell immunotherapies in orphan diseases continues to be recognized by the FDA,” said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. “We believe that the high unmet medical need of immunocompromised patients with antiviral refractory or resistant CMV and compelling ATA230 clinical data provide a strong rationale for continued development. We look forward to further evaluating ATA230 development plans with the FDA and other global health authorities following the initiation of our ATA129 EBV-PTLD Phase 3 studies.”
Orphan drug designation is granted by the FDA to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.
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