FDA approves add-on therapy for patients with genetic form of severely high cholesterol FDA has approved Evkeeza (evinacumab-dgnb) injection as an add-on treatment for patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. HoFH is a rare, life-threatening condition that occurs in approximately 1 in 250,000 individuals. Patients with HoFH have two mutations in a small group of genes that controls the way the body clears cholesterol. As a result, patients have extremely high circulating levels of low-density lipoprotein cholesterol (LDL-C), known as "bad cholesterol." These cholesterol levels can range as high as 500-1,000 mg/dL, more than four times the normal levels. Patients with HoFH can develop premature cardiovascular disease, including heart attack and heart disease, when they are teenagers or in their 20s, and many do not improve with other cholesterol-lowering drugs. Without aggressive treatment, patients may die before age 30. Common side effects of Evkeeza are nasopharyngitis (cold), influenza-like illness, dizziness, rhinorrhea (runny nose), and nausea. Serious hypersensitivity (allergic) reactions have occurred in the Evkeeza clinical trials. Evkeeza may cause harm to a fetus (unborn baby), so prescribers should advise patients about these risks and consider pregnancy testing for patients who may become pregnant before starting treatment. | 
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