Signifor Approved for Cushing's Disease
MONDAY, Dec. 17 -- 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 and gallstones.
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 insufficiency.
Medline Plus has more about Cushing's disease.
Posted: December 2012