Annamycin from Moleculin receives orphan drug status for the Treatment of Acute Myeloid Leukemia
Moleculin Biotech, Inc, a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates.
Release Date: 15-Apr-2017
Moleculin Biotech, Inc, a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, announced that company’s novel product, Annamycin (also known as "Liposomal Annamycin"), an anthracycline has been designated as orphan drug by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). Leukemia is a cancer of the white blood cells and the acute forms of leukemia can manifest quickly and leave patients with limited treatment options. AML is the most common type of acute leukemia in adults.
Orphan Drug Designation is granted to drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon marketing approval for the designated indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and the waiver of prescription drug user fees.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
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