EU approves Signifor (Novartis) for Cushing's Disease

Novartis announced 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 (EU) targeting Cushing's Disease. The approval is based on data from the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's Disease, a disorder caused by excess cortisol in the body due to the presence of a non-cancerous pituitary tumor. In the study, mean urinary-free cortisol (UFC) levels were normalized in 26.3% and 14.6% of the 162 patients randomized to receive Signifor 900�g and 600�g subcutaneous (sc) 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 900�g twice daily. In addition, the study showed the majority of the patients remaining on the study at month six (91 out of 103 patients; 88%) had any reduction in their mean UFC[5]. The median reduction in mean UFC was 47.9% in both dose groups. Reductions in UFC were rapid and sustained through the end of the study, with the majority of patients experiencing a decrease within the first two months.