Pipex Pharmaceuticals Submits Coprexa NDA

Pipex Pharmaceuticals has filed a new drug application (NDA) with the FDA for Coprexa, a treatment for Wilson’s disease, a genetic disorder in which the body is unable to clear excess free copper.

Coprexa (oral tetrathiomolybdate) is used to reduce toxic free copper in serum and has completed two clinical trials in Wilson’s disease patients.

The company also has completed a 20-patient, one-year, open-label Phase I/II trial in refractory idiopathic pulmonary fibrosis patients and is planning a Phase III trial. If the trial is successful, Pipex said it may file a supplemental NDA for this indication.