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The FDA grants annamycin Orphan Drug Designation for the treatment of AML

Mar 24, 2017

On 22 ndMarch 2017, the U.S. Food and Drug Administration(FDA) granted Orphan Drug Designation to annamycin  for the treatment of patients with Acute Myeloid Leukemia (AML). 1

Current anthracyclines such as doxorubicin used in standard chemotherapy for AML patients are associated with risk of cardiotoxity as well as drug resistance. 2  Annamycin(liposomal annamycin) is a liposome-encapsulated  form of the anthracycline doxorubicin, with antineoplastic activity. Annamycin evades cellular Multidrug-Resistance (MDR) mechanisms and eliminates cardiotoxicity. 1

Moleculin Biotech, the drug manufacturer, is working toward an Investigative New Drug application for a phase I/II trial with annamycin for second line treatment in patients with Relapsed or Refractory AML. 1

  1. BioSpace: Moleculin Biotech (MBRX) Receives Orphan Drug Designation For Annamycin For The Treatment Of Acute Myeloid Leukemia. 2017 Mar 22.[Accessed 2017 Mar 23].
  2. Jungsuwadee P.Doxorubicin-induced cardiomyopathy: an update beyondoxidative stress and myocardial cell death. Cardiovasc Regen Med. 2016; 3: e1127. DOI: 10.14800/crm.1127.