FDA panel recommends approval for Novartis Cushing's disease drug

EAST HANOVER, N.J. — A Food and Drug Administration expert panel has voted unanimously in favor of approval for a Novartis drug for a rare endocrine disorder.

Novartis said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted to support approval for Signifor (i.e., pasireotide) for patients with Cushing's disease who require medical therapeutic intervention. Cushing's disease is a form of Cushing's syndrome that affects one- to two-in-1 million people per year, and results from excessive amounts of the metabolic hormone cortisol — resulting in weight gain, severe fatigue, depression and anxiety and other symptoms.

"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," Novartis Oncology president Herve Hoppenot said. "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."

FDA advisory committee recommendations are not binding, and the FDA is not required to follow them when deciding whether to approve a drug, but usually does.


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