Golden Biotechnology Corporation, a company developing a new drug for cancer, announced that it has been granted the Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) Office of Orphan Products Development for the company’s lead drug candidate: Antroquinonol. Antroquinonol received the Orphan Drug Designation in the Treatment of Acute Myeloid Leukemia (AML).(FDA Designation Request #15-4763). The FDA’s decision to grant GoldenBiotech’s orphan-drug status for Antroquinonol is a significant milestone for GoldenBiotech and recognizes the need for innovative new ways to treat AML. GoldenBiotech is expecting the completion of its clinical trials for Acute Myeloid Leukemia (AML) in 2017.
The FDA grants orphan-drug designation to novel development-stage therapeutics that are intended for use in treating rare diseases and medical conditions that affect fewer than 200,000 patients in the US. Orphan-drug status provides sponsors with development and commercial incentives under the Orphan Drug Act in 1983, including tax credits for qualified clinical testing. GoldenBiotech will enjoy seven years of market exclusivity in the United States if the drug receives marketing approval from the FDA.”
AML is an aggressive cancer of the blood and bone marrow characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and prevent the production of other normal blood cells. It is estimated that about 1.2% of overall cancer patients will be diagnosed with AML in the United States; the five-year overall survival is 20% after application of chemotherapy.
Antroquinonol has demonstrated breakthrough clinical effects on cancer treatment along with other multiple indications of new research paths in progress. The Taiwanese’s research demonstrates global competitiveness and continually targets the global markets in hope of acquiring patents for more than 20 indications including NSCLC, Pancreatic Cancer and AML in over 103 countries. The approval of these drugs represents a major public health accomplishment toward treating this life-threatening disease.