Climbing the mountain toward EU and US approval is a new cholesterol treatment called evolocumab (no name yet other than AMG-145). Have you heard of the PCSK9 inhibitor family? Probably not, but it’s worth a closer look and the Amgen molecule may be the first out of the box.
PCSK9 is short for Proprotein convertase subtilisin/kexin type 9. Phew, it’s a mouthful that may be an injected monoclonal antibody to lower cholesterol in people who don’t tolerate statins (HMG-CoA reductase inhibitors lie Lipitor or Crestor). This approach may also allow for lowering of statin doses (which may lower risk of possible blood sugar problems and muscle inflammation and mental status changes as well).
Amgen submitted a Marketing Authorization Application (MAA- something like a new drug application to the FDA) to the European Medicine Agency (EMA) last December. Clinical studies have been very strong so fat and include the phase 3 GAUSS-2 (Global Achievement after Utilizing an anti-PCSK9 antibody in Statin intolerant Subjects) study which looked at lowering cholesterol in people who couldn’t tolerate statins. Ongoing work is continuing in the FOURIER phase 3 study which looks at cholesterol lowering and risk over what may be up to 5 years.
You will be hearing more about PCSK9 beyond atherosclerosis, cholesterol and heart disease as PCSK9 appears to have a role in triglyceride metabolism as well, making it a reasonable target for that problem as well. The American College of Cardiology meeting in March or the American Heart Meeting in November are logical places for more data to be revealed. See the studies at www.clinicaltrials.gov and they will be covered here at www.EssentialGuideToPrescripti... as well.