FDA grants orphan drug designation to annamycin for soft tissue sarcoma
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The FDA granted orphan drug designation to annamycin for the treatment of patients with soft tissue sarcoma, according to a manufacturer-issued press release.
Annamycin (Moleculin Biotech) is a next-generation liposome-formulated anthracycline designed to eliminate cardiotoxicity and avoid multidrug resistance mechanisms associated with other approved anthracyclines.
The agent also received FDA investigational new drug status, allowing it to be studied in a phase 1b/phase 2 clinical trial in the U.S. for patients with soft tissue sarcoma that metastasized to the lungs after first-line therapy. Data have shown that annamycin can reach six- to 34-fold higher levels in the lungs than doxorubicin, the primary first-line therapy for soft tissue sarcoma.
“This is now the second orphan drug designation for annamycin, as annamycin previously received orphan drug designation for the treatment of relapsed or refractory acute myeloid leukemia,” Walter Klemp, chairman and CEO of Moleculin, said in the press release.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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