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FDA grants orphan drug status to Synta and GSK’s elesclomol

Synta Pharmaceuticals and GlaxoSmithKline have reported that FDA has granted orphan drug designation to elesclomol for the treatment of patients with metastatic melanoma.

Elesclomol (formerly STA-4783) is being developed under a global collaboration agreement between Synta and GlaxoSmithKline (GSK). Orphan drug status is designed to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases which affect fewer than 200,000 people in the US.

Eric Jacobson, senior vice president and chief medical officer, Synta, said: “We are pleased that the FDA granted elesclomol orphan drug status for the treatment of metastatic melanoma. With the incidence of melanoma increasing more rapidly than any other cancer during the past ten years, there is a significant need for innovative therapies such as elesclomol.”