Signifor Approved for Cushing's Disease
In cases that cannot be treated through surgery
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.
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 hyperglycemia management and the potential for acute liver injury and adrenal insufficiency.