FDA grants GSK, Synta’s elesclomol US orphan drug designation

Source: Healthcare Exec

Date :28/01/2008 14:40:29

GlaxoSmithKline and Synta announce that elesclomol, its treatment for metastatic melanoma treatment has been granted US orphan drug designation by the Food and Drug Administration.

In November 2006, Elesclomol, which is an investigational drug, received Fast Track designation from the FDA for development in metastatic melanoma, the most deadly form of skin cancer.

Elesclomol, which is in late-stage trials, is being developed under a global collaboration agreement between US biotechnology firm Synta and the British drugmaker.

Orphan drug status

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 United States.

“Orphan drug status is an acknowledgment of the significant need to develop new therapies for patients with metastatic melanoma, a disease for which there are few treatment options,” said Paolo Paoletti, Senior Vice President of the Oncology Medicine Development Center at GSK.

“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,” said Eric Jacobson, M.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals.

January 28, 2008