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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

Patients with primarily moderate to severe hypercortisolism were randomized to receive pasireotide sc injection in doses of 900 micrograms (n=80) or 600 micrograms (n=82) twice daily. The primary endpoint was the proportion of patients who achieved normalization of UFC after six months without dose up-titration relative to randomized dose. The primary endpoint was met in patients treated with 900 microgram sc twice daily. Secondary endpoints included safety, proportion of patients with UFC </= ULN at months 3, 6 and 12 regardless of dose titration, proportion of patients with partial UFC control (defined as UFC > ULN and >/= 50% reduction from baseline); changes from baseline in plasma adrenocorticotropic hormone (ACTH), UFC, serum and salivary cortisol over time and changes from baseline in clinical signs, symptoms and health-related quality of life(1).

After six months, the primary efficacy responder rate was 26.3% (95% confidence interval [CI], 16.6 to 35.9) and 14.6% (95% CI, 7.0 to 22.3), respectively, for the 900 microgram and 600 microgram groups. Based on pre-specified criteria (lower bound of 95% CI >15%), the 900 microgram group met the primary endpoint and the 600 microgram group did not meet the primary endpoint. After 12 months, the proportion of responders regardless of dose up-titration was 25.0% and 13.4%, respectively, for the 900 microgram and 600 microgram groups. The median reduction in UFC after six months was 47.9% for both groups. The median reduction in UFC after 12 months was 62.4% (900 microgram) and 67.6% (600 microgram). In patients with full or partial control of UFC levels at months 1 or 2, 71.4% remained on treatment until month 12 compared with 24.6% of those uncontrolled at months 1 and 2(1).

Adverse events associated with cortisol levels below the normal range were experienced by 13 patients. This was managed by dose reduction without loss of efficacy. There were no deaths during pasireotide treatme
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SOURCE Novartis Pharmaceuticals Corporation
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