Signifor Approved for Cushing's Disease12/17/12
MONDAY, Dec. 17 (HealthDay News) -- Signifor (pasireotide
diaspartate) has been approved by the U.S. Food and Drug
Administration to treat Cushing's disease in cases that cannot be
treated by surgery.
Cushing's occurs when the body overproduces cortisol, a hormone
made by the adrenal glands. Cortisol helps regulate the body's
reaction to stress and injury. People with Cushing's may be
overweight, glucose intolerant, diabetic, have high blood pressure,
bruise easily and be at increased risk of infection, the agency
said in a news release.
Signifor was evaluated in a clinical study of 162 people with
Cushing's disease, and a reduction in cortisol production was seen
in as little as one month. About 20 percent of people had cortisol
levels within the normal range by the end of the six-month study,
the FDA said.
The most common adverse reactions to the twice-daily injected
drug included high blood sugar, diarrhea, nausea, abdominal pain
The agency said it is requiring the drug's Swiss maker,
Novartis, to conduct three post-approval studies to evaluate
Signifor's effects on factors including high blood sugar
management, and the potential for acute liver injury and adrenal
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