Novartis announced that the FDA has approved Signifor (pasireotide) injection for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

The approval is based on data from PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio – CUSHING’S disease), a large randomized Phase 3 study evaluating medical treatment in patients with Cushing’s disease. Results from the PASPORT-CUSHINGS study found that a decrease in mean urinary-free cortisol (UFC), the key measure of biochemical control of the disease, was sustained during the treatment period in most patients with a subset of patients reaching normal levels. Also, the study showed that certain clinical manifestations of Cushing’s disease tended to improve.

Pasireotide targets multiple subtypes of the receptor for somatostatin (sst), a hormone that controls the pituitary gland. Its highest affinity is to sst5, a receptor subtype frequently expressed by the pituitary tumors associated with Cushing’s disease.

Signifor injections will be available in 0.3mg/mL, 0.6mg/mL, and 0.9mg/mL dosage strengths in boxes containing 60 ampules. It is expected to be available in March 2013.

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