Moleculin Biotech Says EMA Grants Orphan Drug Designation To Annamycin To Treat AML

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Moleculin Biotech Says EMA Grants Orphan Drug Designation To Annamycin To Treat AML

(RTTNews) - Pharmaceutical company Moleculin Biotech, Inc. (MBRX) announced Thursday that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Annamycin for the treatment of Acute Myeloid Leukemia (AML).

Annamycin is the Company's next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has shown to be non-cardiotoxic in the 82 subjects treated in multiple studies in the U.S. and in Europe.

Annamycin is currently in development for the treatment for AML and STS lung mets, and the Company believes the drug may have the potential to treat additional indications.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets.

Tag: MOLE.L
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