FDA Advisory Committee Backs Novartis’ SigniforR

An advisory committee for the US Food and Drug Administration has unanimously recommended that the health regulator approve Novartis’ SigniforR drug.

An advisory committee for the US Food and Drug Administration has unanimously recommended that the health regulator approve Novartis’ SigniforR drug for treating Cushing's disease patients who require medical therapeutic intervention.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) said that it has based its recommendation following the results of various studies, including PASPORT-CUSHINGS, which revealed that the drug rapidly reduced the mean urinary-free cortisol (UFC), the key measure of biochemical control of the disease.

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The committee also acknowledged that the drug led to hyperglycemia and elevations in liver enzymes in the patients but said that lack of other therapies for treating the condition means that the benefits outweighed the side effects. “In spite of significant concerns about hyperglycemia and uncontrolled diabetes, I think it's very highly probable that those glucose levels can be adequately controlled with available medications for managing diabetes, including insulin”, Brown University’s Robert Smith, who was part of the panel, said.

Source-Medindia

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