Novartis announced that the Food and Drug Administration (FDA) has approved Signifor LAR (pasireotide diaspartate long-acting release) injectable suspension for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
The FDA approval was supported by two Phase 3 multicenter trials, C2305 and C2402. Both studies evaluated medically naive patients who have had prior surgery or for whom surgery was not an option, as well as patients with acromegaly inadequately controlled on first generation somatostatin analogs (SSA). Greater full biochemical control (mean GH level <2.5mcg/mL and normal IGF-1 levels) was obtained with Signifor compared to a first-generation SSA.
Signifor injection is a cyclohexapeptide somatostatin analog currently approved for treatment of adults with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
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