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CHMP recommends Signifor (Novartis) for treatment of Cushing's Disease

Read time: 1 mins
Last updated:21st Jan 2012
Published:21st Jan 2012
Source: Pharmawand
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Signifor (SOM230, pasireotide)from Novartis for the treatment of Cushing's Disease. There are currently no approved medicines in the European Union targeting Cushing's Disease, a debilitating endocrine disorder caused by excess cortisol in the body due to the presence of a non-cancerous pituitary tumor.The CHMP positive opinion is based on data from the Phase III PASPORT-CUSHINGS trial, the largest randomized study to evaluate a medical therapy in patients with Cushing's Disease. see Colao, A. "Pasireotide (SOM230) provides clinical benefit in patients with Cushing's disease: results from a large, 12-month, randomized-dose, double-blind, Phase III study." Abstract# OC1.7. European Neuroendocrine Association (ENEA) 14th Congress.

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