Pipex files NDA with FDA for copper regulating drug

ANN ARBOR, Mich. Pipex Pharmaceuticals has filed a new drug application with the Food and Drug Administration for Coprexa, a treatment for Wilson’s disease, a genetic disorder in which the body is unable to clear excess free copper.

The company has just 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 for Wilson disease patients.

The drug is used to reduce toxic free copper in serum. At the beginning of the week, Pipex had entered into a cooperative research and development agreement with the Veterans Affairs Medical Center to evaluate Coprexa.