Second Approval in New Cholesterol Rx Class

Repatha (evolocumab), from Amgen, approved to treat high LDL cholesterol by FDA

(RxWiki News) Following the recent approval of a first-in-its-class cholesterol medication, a second treatment in this class received the green light from the FDA.

That drug is Repatha (evolocumab), and it's an injectable PCSK9 inhibitor. The US Food and Drug Administration (FDA) approved it Thursday to treat high cholesterol in adults who haven't seen progress with current treatments.

“Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” said John Jenkins, MD, director of the FDA's Office of New Drugs, in a press release. “Cardiovascular disease is a serious threat to the health of Americans, and the FDA is committed to facilitating the development and approval of effective and safe drugs to address this important public health problem.”

Not all cholesterol is bad. But low-density lipoprotein (LDL) cholesterol has been linked to heart disease.

Like its counterpart, Praluent (alirocumab) — the first PCSK9 inhibitor to receive FDA approval — Repatha is thought to fight high LDL cholesterol by targeting the PCSK9 protein in the body. When functioning, this protein blocks the body's ability to remove LDL cholesterol from the body. Repatha is thought to block PCSK9's function.

The FDA approval of this Amgen drug came after several trials of Repatha suggested that it was safe and effective. One of these studies found that patients who were unable to adequately lower their LDL cholesterol through a common type of cholesterol medication called statins saw a 60 percent average reduction in LDL when they took Repatha for 12 weeks.

Patients in these studies did report some side effects, however. These included respiratory infections, back pain and skin reactions at the injection site, among others.

Review Date: 
August 27, 2015