GSK drug gets orphan status from FDA

RALEIGH, N.C. The Food and Drug Administration has approved skin cancer treatment elesclomol, developed by GlaxoSmithKline, for orphan status.

The designation means that the drug will be allowed seven years of exclusivity if it is brought to the market. Orphan status is given to drugs treating diseases that affect fewer than 200,000 people in the United States.

Elesclomol, indicated for the treatment of metastatic melanoma, is currently in Phase III trials. GSK and its partner in development Synta Pharmaceuticals have indicated that they plan to begin testing to determine other indications for the drug as well.