PCSK9 antibodies are safe and effective, analysis concludes

A new analysis published in the Annals of Internal Medicine concluded that PCSK9 antibodies are safe and effective for adults with high cholesterol.

Researchers looked at over 10,000 patients in 24 Phase-II and Phase-III trials and found that patients treated with PCSK9 inhibitors were less likely to have a heart attack and less likely to die from all causes compared to patients not taking an antibody.

PCSK9 inhibitors have been touted as a new and highly effective way to lower LDL (i.e., “bad”) cholesterol levels in patients. Sanofi/Regeneron and Amgen have both filed PCSK9 treatments with the FDA. The agency is expected to make a decision on Sanofi’s Praluent (alirocumab) on July 24, while Amgen’s Repatha (evolocumab) should receive a ruling on Aug. 27.