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BY OUR PHARMA CORRESPONDENT
15 September,2005: The federal drugs regulator in US has deemed Abbott’s investigational drug against prostate cancer atrasentan unapprovable.
The US Food and Drug Administration (FDA) decision not to approve the oral investigational agent Xinlay (atrasentan) has been made on the recommendation of its Oncology Drug Advisory Committee (ODAC). The drug has been studied for the treatment of patients with hormone-refractory prostate cancer (HRPC) that has spread to the bone, Abbott announced.
Xinlay is an investigational, oral, once-daily, non-hormonal, non-chemotherapy, agent that belongs to a class of compounds known as selective endothelin-A receptor antagonists (SERA). SERAs antagonize the effect of endothelin-l (ET-l), one of the proteins thought to be involved in the stimulation of the growth and spread of cancer cells. Abbott submitted a New Drug Application (NDA) in December 2004 seeking approval. The NDA for Xinlay supplied data on time to disease progression and delay in time to onset of bone pain.
The drug is being studied in earlier stage prostate cancer patients in an ongoing phase III study in hormone-refractory prostate cancer patients without metastasis. This study is expected to be completed in 2006.
Abbott is a global health care company developing pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
BY OUR PHARMA CORRESPONDENT |
