The designation was granted for the use of Genasense for patients with stage IV malignant melanoma. Orphan drug designation is intended to facilitate the development of drugs that address significant unmet medical needs.
The status provides seven years of market exclusivity after approval, grants and tax credits for research and development and reduced filing fees for marketing applications.
“Melanoma is an especially serious public health problem in Australia,” said Dr Raymond Warrell, Genta's CEO. “The recently published phase III study of Genasense plus dacarbazine included a large number of Australian participants and showed benefit across an array of clinical endpoints.”
Genta has filed a marketing authorization application that is currently under review with the European Medicines Agency for the use of Genasense plus dacarbazine for treatment of patients with advanced melanoma.