Swiss drug giant Novartis AG (NVS) said Sunday that the US Food and Drug Administration has approved Signifor (pasireotide) injection as the first medicine to be approved in the US that addresses the underlying mechanism of Cushing's disease. The drug is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
"The FDA approval of Signifor for Cushing's disease brings a novel pituitary-directed therapy to patients with limited treatment options. Today's milestone reinforces Novartis' commitment to addressing unmet needs and advancing treatments for rare pituitary-related disorders," said Hervé Hoppenot, President, Novartis Oncology.
The approval comes 45 days after the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously to recommend the use of Signifor as the only pituitary-directed therapy. Th panel approval was based on late stage trial data which showed that mean urinary-free cortisol (UFC), the key measure of biochemical control of the disease, was rapidly decreased and sustained in most patients.
Cushing's disease is a serious, debilitating endocrine disorder caused by the presence of a non-cancerous pituitary tumor which ultimately leads to excess cortisol in the body, which is triggered by an adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma. It can cause severe illness and death with mortality up to four times higher than in the healthy population.
It is a rare but serious disease that affects about one to two patients per million per year, and commonly affects adults as young as 20 to 50 years. It has a tendency to affect women three times more often than men.
The European Commission approved Signifor in April 2012 for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed.
Other worldwide regulatory filings for pasireotide for this use are also underway. Pasireotide is a multireceptor targeting somatostatin analog that binds with high affinity to four of the five somatostatin receptor subtypes.
NVS closed Friday's regular trading session at $63.19, up $0.12 or 0.19% on a volume of 1.81 million shares.
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