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news.The FDA has granted orphan drug designation to SciClone Pharmaceuticals' investigational drug Zadaxin for the treatment of stage IIb through stage IV malignant melanoma, or skin cancer.
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Orphan drug designation could provide SciClone with seven years of market exclusivity in the US should Zadaxin receive regulatory approval from the FDA for the treatment of malignant melanoma.
“We are extremely excited to receive this designation, which we believe emphasizes the pressing need for new therapeutic options that may improve the currently bleak prospects for patients with advanced stages of malignant melanoma,” commented Dr Ira Lawrence, president and CEO of SciClone Pharmaceuticals.
Zadaxin is currently being investigated in combination with dacarbazine (DTIC) chemotherapy with and without low-dose interferon alpha in a large, multi-centered phase II stage IV malignant melanoma trial in Europe. This trial is being conducted by Sigma-Tau, SciClone’s European development and marketing partner.
In December 2005, SciClone reported encouraging interim data on overall tumor response showing a distinct ZADAXIN dose-dependent response in combination with DTIC chemotherapy with and without low-dose interferon alpha.