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news.Oncology-focused pharmaceutical firm Callisto has received notification from the FDA regarding the agency's decision to award orphan drug designation to the company's drug candidate Annamycin for use in the treatment of acute myeloid leukemia.
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The Orphan Drug Act is intended to encourage the development of products for rare diseases affecting fewer than 200,000 people in the US. Callisto’s orphan drug designation entitles the company to seven years of market exclusivity in the US. During this period, the FDA will not accept or approve other applications to market the same medicinal product for the same therapeutic indication.
Annamycin, a second-generation anthracycline, is currently being developed to treat both acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) patients. A single-agent clinical trial of Annamycin in adult relapsed ALL patients is expected to proceed shortly.
Callisto is also planning to initiate a clinical trial of Annamycin in combination with Ara-C in adult relapsed AML patients this year.