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news.Global healthcare firm Abbott has announced that the FDA has agreed to file the company's new drug application for Xinlay, an oral agent for the treatment of metastatic hormone-refractory prostate cancer.
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This acceptance for filing indicates that the new drug application (NDA) is sufficiently complete to permit a substantive review of the data supporting Xinlay’s safety and effectiveness.
Abbott’s NDA for Xinlay (atrasentan), a selective endothelin-A receptor antagonist (SERA), is based on phase II and III clinical trials in men with metastatic hormone-refractory prostate cancer. The NDA submission supplies data regarding the effect of Xinlay on disease progression and delay in time to onset of bone pain.
“The FDA acceptance of an application is a critical step in our goal of making new therapies that are less toxic available to patients,” said Dr John Leonard, vice president of global pharmaceutical development at Abbott.
Abbott expects a response from the FDA regarding its application in the fourth quarter of 2005.