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Juxtapid Approved for LDL Cholesterol Condition
Disorder affects about 1 million in U.S.
Wednesday, January 2, 2013
WEDNESDAY, Jan. 2 (HealthDay News) -- Juxtapid (lomitapide) has been approved by the U.S. Food and Drug Administration to treat a rare inherited disorder in which the body is unable to remove low-density lipoprotein (LDL) "bad" cholesterol from the blood.
Homozygous familial hypercholesterolemia (HoFH) affects about 1 million people in the United States, the agency said in a news release. The inability to remove LDL cholesterol from the blood often causes heart attacks and death before age 30, the FDA said.
Juxtapid, a once-daily capsule, is meant to be taken without food at least two hours before the evening meal, the agency said.
The drug was evaluated in a clinical study of 29 people with HoFH, causing a drop in LDL levels of about 50 percent in 26 weeks among those who tolerated the treatment. The drug's label carries a boxed warning of the potential for serious liver poisoning and progressive liver disease, the FDA said.
The most common clinical side effects noted were diarrhea, nausea, vomiting, indigestion and abdominal pain.
Juxtapid is marketed by Aegerion Pharmaceuticals, based in Cambridge, Mass.
Homozygous familial hypercholesterolemia (HoFH) affects about 1 million people in the United States, the agency said in a news release. The inability to remove LDL cholesterol from the blood often causes heart attacks and death before age 30, the FDA said.
Juxtapid, a once-daily capsule, is meant to be taken without food at least two hours before the evening meal, the agency said.
The drug was evaluated in a clinical study of 29 people with HoFH, causing a drop in LDL levels of about 50 percent in 26 weeks among those who tolerated the treatment. The drug's label carries a boxed warning of the potential for serious liver poisoning and progressive liver disease, the FDA said.
The most common clinical side effects noted were diarrhea, nausea, vomiting, indigestion and abdominal pain.
Juxtapid is marketed by Aegerion Pharmaceuticals, based in Cambridge, Mass.
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