Drug OK'd for deadly genetic condition tied to cholesterol

(HealthDay)—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 (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 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 .

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.

More information: To learn more about high cholesterol, visit the U.S. National Library of Medicine.

add to favorites email to friend print save as pdf

Related Stories

FDA approves juxtapid for rare cholesterol disorder

Dec 27, 2012

(HealthDay)—The U.S. Food and Drug Administration has approved the orphan drug Juxtapid (lomitapide) for patients with homozygous familial hypercholesterolemia (HoFH), for use in combination with a low-fat ...

Canadian scientists discover cause of high cholesterol

Oct 28, 2012

Canadian scientists have discovered that a protein called resistin, secreted by fat tissue, causes high levels of "bad" cholesterol (low-density lipoprotein or LDL), increasing the risk of heart disease.

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

Oct 24, 2014

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments