The USFDA has approved Novartis' Signifor (pasireotide) injection to treat Cushing's disease, an endocrine disorder.
The only approved pituitary-directed therapy in the US, for the patients who are not suitable for pituitary surgery, addresses the principal mechanism of Cushing's disease.
Novartis Oncology president Herve Hoppenot said Signifor approval for Cushing's disease allows the pituitary-directed therapy available to patients with limited treatment options.
"Today's milestone reinforces Novartis' commitment to addressing unmet needs and advancing treatments for rare pituitary-related disorders," Hoppenot added.
Positive study data from Phase III randomized PASireotide clinical trial PORTfolio - CUSHING'S disease (PASPORT-CUSHINGS) has formed the basis for the approval.
PASPORT-CUSHINGS demonstrated continuous decrease in average urinary-free cortisol during the treatment period in the majority patients while a division of patients established normal levels.
