Pasireotide recommended for Cushing's disease

EAST HANOVER, NJ – The US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in support of the use of Novartis’ Signifor (pasireotide) for the treatment of Cushing’s disease requiring medical therapeutic intervention.

"We are encouraged by today's favorable advisory committee recommendation for pasireotide in Cushing's disease and will work closely with the FDA as it completes its review of our application," said Herve Hoppenot, president, Novartis Oncology. "There is a significant unmet medical need for Cushing's disease patients and Novartis is committed to providing the endocrinology community with a novel therapeutic approach for this rare and debilitating endocrine disorder."

Cushing’s syndrome is an endocrine disorder caused by excessive cortisol, a hormone for metabolism regulation, maintenance of cardiovascular function, and stress response. Cushing’s disease is a form of the syndrome triggered by an adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma. The disease affects approximately one to two patients per million per year.