Summary
Abbott Laboratories (ABT) announced on June 23, 2005, that it has received U.S. Food and Drug Administration (FDA) permission to initiate an expanded access program for its investigational drug, Xinlay™ (atrasentan). This program will make Xinlay available to eligible men with late-stage, hormone-refractory prostate cancer, for whom limited treatment options currently exist. The program is set to commence later in the summer. The expanded access program is designed to provide early access to investigational treatments for serious diseases lacking satisfactory alternatives. Xinlay's New Drug Application (NDA) is currently under FDA review, based on clinical trial data demonstrating potential benefits in delaying disease progression and bone pain onset in men with metastatic hormone-refractory prostate cancer. This filing provides crucial insight into Abbott's efforts to address a significant unmet medical need in prostate cancer treatment.
Key Highlights
- 1Abbott Laboratories has secured FDA permission for an expanded access program for its investigational prostate cancer drug, Xinlay™ (atrasentan).
- 2The program targets eligible men with late-stage, hormone-refractory prostate cancer, a condition with limited treatment alternatives.
- 3Xinlay is an investigational, oral, once-daily, non-hormonal, non-chemotherapy agent belonging to the selective endothelin-A receptor antagonist (SERA™) class.
- 4The FDA is currently reviewing a New Drug Application (NDA) for Xinlay, based on Phase II and III clinical trial data.
- 5Clinical data for Xinlay supports its potential to delay disease progression and the onset of bone pain.
- 6The expanded access program is scheduled to begin later in the summer of 2005.
- 7This initiative demonstrates Abbott's commitment to addressing significant unmet needs in prostate cancer therapy.