Novartis AG (NOVN)’s treatment for Cushing’s disease helped some patients, potentially providing a second marketed therapy for the rare condition, U.S. regulators said.
The drug known as pasireotide decreases levels of the hormone cortisol, which in excess cause Cushing’s, Food and Drug Administration staff said today in a report. The disease leads to obesity, skin that bruises easily, excess hair growth in women and decreased sexual desire in men, according to the National Institutes of Health.
The drug, which Basel, Switzerland-based Novartis proposes calling Signifor and is approved in Europe, would be an alternative to surgery to remove tumors that are the cause of the excess hormone. FDA staff cautioned some patients experienced increased levels of an enzyme in the blood that indicates liver damage and others had high sugar levels.
“The above-described efficacy results need to be considered in the context of the overall safety profile observed in the pasireotide clinical program,” FDA staff wrote.
An FDA advisory committee is scheduled on Nov. 7 to discuss whether the therapy’s efficacy outweighs the safety concerns. The FDA approved in February the first treatment for Cushing’s, a once-daily pill from Corcept Therapeutics Inc. (CORT) called Korlym.
In the Novartis drug, mean levels of cortisol measured in urine normalized after six months in 26 percent of 80 patients who received twice daily injections of the highest dose of pasireotide in a final-phase study, according to the report. Of 82 patients on a lower dose, 15 percent experienced normalized cortisol levels. Body weight, blood pressure and cholesterol levels also were significantly reduced, according to the study.
Corcept’s Korlym doesn’t decrease cortisol levels, the FDA said when it approved the drug. The pill reduces the effects of the hormone, such as controlling high blood-sugar levels. One of the side effects of pasireotide is hyperglycemia, or high blood sugar, that can cause frequent urination and increased thirst. If left untreated, hyperglycemia can lead to diabetic coma.
Of the 162 patients who took the Novartis drug, 73 percent had a hyperglycemia-related adverse event, according to the report.
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