«Libvendra»... A Therapeutic Option for Patients with High Cholesterol

The U.S. Food and Drug Administration (FDA) has approved Lipfendra, making it the first oral drug in the class of PCSK9 inhibitors to be approved for lowering harmful blood cholesterol levels, after this class of medications had been available exclusively as injections for nearly a decade.

According to a statement from the U.S. agency, the new drug, produced by Merck, is used as an adjunct to diet and exercise to lower low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with the familial form.

Merck stated in a press release that Lipfendra is an innovative macrocyclic peptide that works by binding to PCSK9 and preventing its interaction with LDL cholesterol receptors on the surface of liver cells, thereby allowing more receptors to remove this cholesterol from the bloodstream.

The new drug is taken as a 20-milligram dose once daily on an empty stomach in the morning with water, black coffee, or unsweetened tea, with patients required to wait at least 30 minutes before consuming any other food or beverage.

The FDA’s approval was based on results from two Phase 3 clinical trials involving 3,207 patients receiving the maximum tolerated dose of statins. The trials showed reductions in LDL cholesterol of 56% and 59%, respectively, compared with two placebos, while participant adherence to prescribed doses reached 97%.

Prior to the approval of Lipfendra, PCSK9 inhibitors were available exclusively as injections produced by other U.S. companies.

* Stated cost: Approximately $10.50 per day, or about $315 per month, compared with $500 to $600 per month for some injections.

In this context, U.S. media quoted Dr. Dean Li, head of research laboratories at Merck, describing the approval as a “milestone moment” that provides a new treatment option for patients with high cholesterol, noting that the review process was “rigorous and efficient.”

Specialized medical reports indicated that the efficacy of the new Lipfendra appears comparable to currently available injections in lowering cholesterol. However, the absence of direct comparisons between the two forms to date means that any such comparisons should be read as preliminary indicators rather than definitive results, according to medical sources monitoring the drug’s file.