FDA Grants AbbVie’s PSP Therapy Orphan Drug Status

The US Food and Drug Administration (FDA) has granted orphan drug status to AbbVie and C2N Diagnostics, a life sciences company, for their investigational recombinant humanized anti-tau antibody, C2N-8E12 (ABBV-8E12) for treating progressive supranuclear palsy (PSP). The companies also have begun a Phase I clinical study of C2N-8E12 in patients with PSP.

C2N-8E12 is a humanized antibody targeting the tau protein found in neurofibrillary tangles in the brain of patients with tauopathies such as PSP and Alzheimer’s disease. The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

C2N Diagnostics was founded by Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, Missouri and LifeTech Research, a technology research and venture development firm. C2N is commercializing a suite of biomarker assays and tools to enable drug discovery and clinical drug development for neurodegenerative disorders.

Source: AbbVie

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