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Data in NEJM shows Novartis drug Signifor® is first therapy to provide rapid, durable benefit for Cushing's disease patients in Phase III study
Date:3/7/2012

e of approximately 50% by month two, and remained stable in both groups through the end of the study. On average, as UFC levels were reduced, clinical manifestations of Cushing's disease improved including reduction of blood pressure, total cholesterol, weight and body mass index(1).

The most frequently reported adverse events (AE) (>10%) by investigators for pasireotide were diarrhea, nausea, hyperglycemia, cholelithiasis, abdominal pain, diabetes mellitus, injection site reactions, fatigue and increased glycosylated hemoglobin (HbA1c), with most events being Grade 1-2. The tolerability profile of pasireotide was similar to that of other somatostatin analogs with the exception of the greater degree of hyperglycemia.

The trial, which represents the largest randomized study to evaluate a medical therapy in patients with Cushing's disease, is the basis for regulatory submissions for pasireotide under way worldwide for the treatment of this condition. If approved, the brand name for pasireotide will be Signifor.

"These study results demonstrate that pasireotide has the potential to be an important therapeutic option for patients living with Cushing's disease and reinforces Novartis' commitment to develop therapies to help address unmet medical needs," said Herve Hoppenot, President, Novartis Oncology. "We look forward to working with regulatory authorities worldwide to help bring this novel treatment option to market."

About the Study

PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease) is a prospective randomized, double-blind, Phase III study conducted at 68 sites in 18 countries. The study evaluated the efficacy and safety of pasireotide in 162 adult patients with persistent or recurrent Cushing's disease and UFC levels greater than 1.5 times the upper limit of normal (ULN), as well as in patients with newly diagnosed Cushing's disease who are not candidates for surgery(1).


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