Novartis AG (NOVN)’s Signifor won U.S. regulatory approval to treat the rare hormone condition known as Cushing’s disease.
The Food and Drug Administration cleared the drug for patients who can’t be helped with surgery, the agency said yesterday in a statement. The drug lowers excess levels of the hormone cortisol caused by a tumor on the pituitary gland at the base of the brain. Cushing’s 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 disease falls under the umbrella Cushing’s syndrome, which is caused by excess cortisol that can be stimulated by corticosteroid medications for asthma and rheumatoid arthritis and thyroid, pancreas and lung tumors. Most patients with the condition treat it by surgery to remove the tumor.
“Although surgery tends to be first line therapy to treat Cushing’s disease, Signifor is a new treatment option for patients when surgery hasn’t worked or isn’t an option,” Mary Parks, director of the FDA’s division of metabolism and endocrinology products, said in the statement.
Signifor, a twice-daily injection, lowered body weight, blood pressure and cholesterol levels significantly in a study funded by Basel, Switzerland-based Novartis. It also increased blood sugar levels as soon as two weeks after treatment began.
Novartis will need to conduct three additional studies of Signifor once it reaches the market, the agency said. One will track management of high blood sugar, one will monitor long-term use of the drug and the last will look for signs of risk stemming from high blood sugar, liver damage or adrenal insufficiency.
The FDA approved Menlo Park, California-based Corcept Therapeutics Inc. (CORT:US)’s Korlym, a once-daily pill for high blood- sugar associated with Cushing’s syndrome, in February.
About 2 or 3 people for every 1 million will develop non- medicine related Cushing’s each year in the U.S., according to the National Institutes of Health.
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