C2N-8E12 from AbbVie and C2N Diagnostics granted FDA orphan drug designation

The US Food and Drug Administration has granted orphan drug designation to investigational recombinant humanized anti-tau antibody, C2N-8E12 (ABBV-8E12), from US drugmaker AbbVie (NYSE: ABBV) and C2N Diagnostics.

The designation has been given for the treatment of progressive supranuclear palsy (PSP), and the companies have begun a Phase I clinical study of the drug in this indication. 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.

Joel Braunstein, chief executive of C2N Diagnostics, said: "The FDA's orphan drug designation recognizes the lack of treatment options for patients with PSP, a debilitating neurological disease, and is an important milestone in the development of potential therapies.”