Injectable drug was cleared for use in adults who have failed or are unsuitable for surgery.
The European Commission approved Novartis’ Signifor® (pasireotide) for the treatment of Cushing disease in adult patients who have either failed surgery or who aren’t suitable for surgical intervention. The drug is the first to be approved for Cushing disease in Europe.
Clearance by the EC was based on data from a 162-patient Phase III study, which showed that twice-daily subcutaneous injections of Signifor for six months normalized levels of urinary-free cortisol (UFC) in 26.3% of participants receiving the higher of two doses of the drug. In addition, 88% of patients who remained in the study at month six had reductions in mean UFC, with a median reduction of 47.9% for both the low- and high-dose groups.
Full and partial control of UFC relating to pasireotide therapy also led to reductions in the clinical manifestations of Cushing disease, including blood pressure, total cholesterol, weight, and body mass, at six and 12 months.
Signifor is a multireceptor targeting somatostatin analog that binds to four of the five somatostatin receptor types (sst 1, 2, 3, and 5). EU clearance covers use of the drug as a twice-daily subcutaneous injection. A global Phase III study is also in progress to evaluate a long-acting release, once monthly intramuscular injection formulation.