- The FDA announced the hold on Protagonist's blood diseases drug, rusfertide, less than a month ago. A mouse in one study showed signs of benign and malignant skin tumors. Protagonist reexamined four cases of cancer across rusfertide studies in humans, as well as analyzed its safety database. Researchers didn't find any additional cancer cases or unexpected safety signals.
- Protagonist is studying rusfertide in patients with rare blood diseases, including a type of cancer, polycythemia vera, and hereditary hemochromatosis. The latter is a disease in which the body absorbs too much iron from the diet.
Protagonist Therapeutics announced the FDA removed the full clinical hold on rusfertide clinical studies
- The Company provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, the Company provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the most recent safety database, and included new safety and stopping rules in the study protocols. The Company is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.
- The clinical hold was initially triggered by a recent non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adverse reactions (SUSAR). No additional cancer cases, and no other unexpected safety signals, surfaced in this process.
No comments:
Post a Comment