Juxtapid Approved for LDL Cholesterol Condition

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.

-- Scott Roberts Copyright © 2013 HealthDay. All rights reserved.

View the original article here

Drug OK'd for Deadly Genetic Condition Tied to Cholesterol

WEDNESDAY, Jan. 30 (HealthDay News) -- Kynamro (mipomersen sodium) has been approved by the U.S. Food and Drug Administration to treat a rare inherited condition in which the body can't remove low-density lipoprotein (LDL) cholesterol from the blood.

LDL is the so-called "bad" cholesterol that can clog the arteries and cause heart attack and stroke. Many people with homozygous familial hypercholesterolemia (HoFH) have a heart attack and die before age 30, the FDA said in a news release.

HoFH affects approximately one of every 1 million people in the United States. Kynamro is a once-weekly injection designed to lower creation of blood lipid particles that ultimately form LDL, the agency said.

The drug was clinically evaluated among 51 people with HoFH. Among Kynamro users, LDL levels fell an average of about 25 percent during the first 26 weeks, the FDA said. The drug will carry a "black box" label warning of possible liver abnormalities that could lead to progressive liver disease.

More common side effects noted during clinical testing included injection-site reactions, flu-like symptoms, nausea, headache and elevated liver enzymes.

Kynamro is produced by Genzyme Corp., of Cambridge, Mass.

-- Scott Roberts Health News Copyright © 2013 HealthDay. All rights reserved.

View the original article here