ARTICLE | Clinical News

Novartis' pasireotide meets Cushing's endpoint

September 23, 2010 12:50 AM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) said the higher of two twice-daily doses of subcutaneous pasireotide ( SOM230) met the primary endpoint in the Phase III PASPORT-CUSHINGS trial to treat Cushing's disease, a hormone disorder caused by high levels of cortisol in the blood. The 900 ug dose of the somatostatin analog therapy met the endpoint of the proportion of patients who achieved normalization of their urinary free cortisol (UFC) levels at six months (26.3%; 95% confidence interval: 16.6, 35.9), while the 600 ug dose missed the endpoint (14.6%; 95% CI: 7, 22.3). The threshold to meet the endpoint was indicated by a lower limit of the 95% CI greater than 15. ...