FDA Approves New Drug Treatment For High Cholestrol

Increased cholesterol levels contributes to the increase the risk of having a heart attack. Continuous research is being done to alleviate high cholesterol levels.

Now, the unending search takes another step forward as a new drug approved by the Food and drug Administration could potentially help in controlling the problem.

According to Medical News Today (MNT), the drug Rephata has been approved by the FDA along with the notice that it should be taken with a healthy diet and "maximally-tolerated statin therapy" for individuals who need a reduced amount of low-density lipoprotein cholesterol (LDL-C) because of conditions linked to heart diseases such as heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH).

MNT reported that the drug, whose generic name is evolocumab, is an injection-based treatment that slows down the activity of PCSK9 or Proprotein convertase subtilisin/kexin type 9.

The enzyme is responsible for decreasing low-density lipoprotein receptor (LDLR) and leads to an increase in LDL-C.

Through the drug, PCSK9 is slowed down, resulting to a reduction of the LDL-C, which is commonly tagged as "bad cholesterol" and is linked to inreased risk for heart attack and stroke.

Before being approved by FDA, MNT reported that the drug was evaluated to test both its effectiveness and safety.

In order to determine these, a "52-week placebo-controlled trial" as well as "eight 12-week placebo controlled trial" that was participated by individuals who has HeFH and HoFH was made.

The results revealed that those treated with Rephata showed an almost 60 percent decrease in LDL-C level as compared to those who took a placebo.

"Repatha provides another treatment option in this new class of drugs for patients with HeFH or with known cardiovascular disease who have not been able to lower their LDL-C enough with statins," Dr. John Jenkins, Director of the Office of New Drugs of the Center for Drug Evaluation and Research, said in a press release by FDA. 

However, the organization warned that possible side effects of the drug include "nasopharyngitis, upper respiratory tract infection, flu, back pain, and reactions such as redness, pain, or bruising where the injection is given."

The new drug is only the second FDA approved medicine treatment in the relatively new drug class called "PCSK9 inhibitors", following allrocumab (Praulent) by Sanofi which was approved last July 24.

High cholesterol level is linked to heart attack and possible heart disease.

According to Centers for Disease Control and Prevention, heart disease is the leading cause of death in America. Every year, 610,000 people die of heart disease while 735,000 have a heart attack.

"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," Dr. Jenkins added in the FDA release.