MGI Pharma: Dacogen receives orphan-drug status for patients with acute myeloid leukemia

By E. Janene Geiss

Philadelphia, Aug. 10 - MGI Pharma, Inc. said Thursday that the Food and Drug Administration has granted Dacogen (decitabine) for injection orphan designation for the indication of acute myeloid leukemia.

Dacogen was approved by the FDA on May 2 for the treatment of patients with myelodysplastic syndromes, including previously treated and untreated, de novo and secondary myelodysplastic syndromes of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups, according to a company news release.

Orphan-drug designation was designed to promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people per year in the United States and may provide seven years of market exclusivity following FDA approval.

Dacogen was previously designated as an orphan drug for the myelodysplastic syndromes indication.

Dacogen is being co-developed by MGI Pharma and Janssen-Cilag, a Johnson & Johnson company.

Janssen-Cilag companies are responsible for regulatory and commercial activities in all territories outside North America, while MGI Pharma retains responsibility for all activities in the United States, Canada and Mexico.

Dacogen is a hypomethylating agent that is believed to exert its antineoplastic effects by incorporation into DNA and inhibition of an enzyme called DNA methyltransferase.

MGI Pharma is conducting a phase 3 pivotal trial to evaluate Dacogen in patients with acute myeloid leukemia. Additional phase 2 studies also are underway to evaluate alternative dosing regimens for Dacogen in patients with myelodysplastic syndromes, acute myeloid leukemia and chronic myelogenous leukemia.

A phase 3 study sponsored by the European Organization for Research and Treatment of Cancer in patients with myelodysplastic syndromes is ongoing in Europe, officials said.

MGI Pharma is a Bloomington, Minn., biopharmaceutical company focused in oncology and acute care.

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