FDA orphan drug designations: Zactima, Surfaxin, IL-21

The U.S. Food and Drug Administration (FDA) on October 31, 2005, approved orphan drug designation for ZED6474 (Zactima) for the treatment of follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer. Produced by AstraZeneca, Zactima is being studied in a Phase II trial for treatment of medullary thyroid cancer, and is being reviewed by the European Medicines Evaluation Agency for orphan drug status in Europe.

The FDA approved orphan drug designation for lucinactant (Surfaxin) on October 28, 2005, for the treatment of bronchopulmonary dysplasia (BPD) in premature infants. Discovery Labs, manufacturer of Surfaxin, is currently conducting a Phase II trial to determine the safey and tolerability of lucinactant as a therapeutic approach for prevention of BPD.

The FDA approved orphan drug designation for interleukin 21 (IL-21) on October 5, 2005, for the treatment of advanced or aggressive melanoma. Produced by ZymoGenetics, IL-21 is being evaluated in Phase Ib clinical trials of melanoma and renal cell carcinoma.