MEI Pharma Gets Orphan Drug Status For Pracinostat For Acute Myeloid Leukemia

(RTTNews) - MEI Pharma, Inc. (MEIP), an oncology company focused on the clinical development of novel therapies for cancer, said the U.S. Food and Drug Administration or FDA has granted orphan drug designation to the company's investigational drug Pracinostat for the treatment of acute myeloid leukemia or AML.

According to MEI Pharma's President and Chief Executive, Daniel Gold, "AML is a particularly devastating cancer for which there are currently few broadly effective treatments. Through development of Pracinostat, we hope to address this significant unmet medical need."

The Orphan Drug Designation program offers orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Orphan designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.