Coprexa NDA Not Approved

Pipex Pharmaceuticals has received notice from the FDA that its new drug application (NDA) for Coprexa for the treatment of initially presenting neurologic Wilson’s disease has not been accepted by the FDA for further review as submitted.

Pipex said the deficiencies cited by the FDA had been discussed and resolved with the agency during one of the two pre-NDA meetings for Coprexa (oral tetrathiomolybdate) in August 2007.

The FDA transferred the NDA from the initial review division to a new division in December after determining the new group had the expertise in diseases resulting from inborn metabolic errors.

The company said it believes this transfer may have contributed to the FDA’s decision to deny further review of the application as filed.