Novartis (NVS) said that the European Commission has approved Signifor (pasireotide) for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. Signifor is the first medicine to be approved in the European Union targeting Cushing's disease, a disorder caused by excess cortisol in the body due to the presence of a non-cancerous pituitary tumor.
The decision follows the positive opinion the Committee for Medicinal Products for Human Use adopted for Signifor in January 2012 for the treatment of Cushing's disease and applies to all 27 EU member states, plus Iceland and Norway.
The company noted that the approval is based on data from the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's disease. In the study, majority of patients experienced a rapid and sustained decrease in mean cortisol levels with a subset of patients achieving normalization. Mean urinary-free cortisol (UFC) levels were normalized in 26.3% and 14.6% of the 162 patients randomized to receive Signifor 900µg and 600µg subcutaneous injection twice daily, respectively, at month six. The primary endpoint, the proportion of patients who achieved normalization of UFC after six months without dose up-titration relative to randomized dose, was met in patients treated with 900µg twice daily.
In addition, the study showed the majority of the patients remaining on the study at month six had any reduction in their mean UFC. The median reduction in mean UFC was 47.9% in both dose groups.
by RTT Staff Writer
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