New Drug Treats Rare Hormonal Disorder
November 11, 2007
Sept. 4 — The U.S. Food and Drug Administration has approved Somatuline Depot to treat a rare growth hormone-related disorder called acromegaly, the agency said Friday.
The disorder, caused by an abnormal secretion of the hormone, is characterized by enlarged hands, feet, facial bones, and internal organs such as the heart and liver. If untreated, people with the disorder often die prematurely because of heart and respiratory problems, diabetes, or colon cancer, the FDA said. The disorder affects about 15,000 people in the United States and Canada.
The drug’s safety and effectiveness were evaluated in two clinical trials involving 400 people. The most frequent side effects were diarrhea, gallstones, skin reactions, slow heart rate, and changes in blood sugar levels.
Samatuline Depot is marketed by Beaufour Ipsen, based in Paris, France.
