“We are pleased that the FDA has agreed to remove the clinical hold status of the trials, and we plan to continue to work closely with UCB to make epratuzumab available to patients who were in the suspended trials, and who remain in urgent need,” commented Cynthia Sullivan, president and CEO of Immunomedics.
The FDA placed the study on hold over concerns about sterility after a routine audit of the end-stage manufacturing processes.
Immunnomedics said protocol amendments would be submitted to Institutional Review Boards to seek approval to treat patients who remain on the currently suspended studies, and who are in need of re-treatment.
Immunomedics is a New Jersey-based biopharmaceutical company focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases.