The United States (US) Food and Drug Administration (FDA) has approved a first-of-its-kind pill that can drastically reduce bad cholesterol.
The treatment was previously available only through expensive injectable drugs.
The medication, developed by Merck, has been approved for patients whose artery-clogging cholesterol remains high despite taking statins. Statins are the standard medications used to lower the risk of heart attacks.
Merck will sell the pill under the brand name Lipfendra.
It is the first non-injectable drug that works by blocking a liver protein known as PCSK9. The protein limits the body’s ability to remove cholesterol from the blood.
Injectable drugs targeting PCSK9 have been available from Amgen and other pharmaceutical companies for more than a decade.
However, access to these treatments has remained limited because of high prices, insurance restrictions, and low prescribing rates among doctors.
Statins reduce some of the cholesterol produced by the liver and remain the main treatment for high cholesterol.
However, even the highest doses are not enough for many patients to lower their low-density lipoprotein, or LDL, cholesterol to the levels recommended under medical guidelines.
LDL is commonly known as bad cholesterol.
Merck secured the approval after conducting two studies involving high-risk patients. Participants added Lipfendra to their existing treatments, including statins.
In one study involving 3,000 patients, those taking the pill recorded a reduction of more than 55 percent in their LDL cholesterol levels after six months.
In the second study, patients taking Lipfendra recorded an average reduction of 59 percent compared with those who received a placebo.
The benefits declined only slightly over a period of one year.
Researchers also found that side effects, including dizziness and diarrhea, were reported at similar rates among people taking Lipfendra and those receiving a placebo.
However, the pill must be taken on an empty stomach.
The FDA reviewed the medication under a program designed to provide extremely fast reviews for promising drugs that serve the public interest.
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