PCSK9 Inhibitors have been making headlines for the past few months now. These LDL-slashing drugs have been under scrutiny by payers due to their high anticipated prices. Most recently, the FDA is taking a much closer look into two of these drugs: evolocumab from Amgen, which is to be sold under the brand name Repatha®, and alirocumab from Regeneron/Sanofi, which is to be sold under the brand name Praluent®. The main purpose of this advisory board is to discuss the designated endpoints for cutting LDL for cardiovascular benefits, and also any potential negative effects that these drugs could have on the current demand for statins.

On June 9th, and June 10th, the Center for Drug Evaluation and Research (CDER) Endocrinologic and Metabolic Drug Advisory Committee of the FDA is scheduled to discuss and evaluate the safety and efficacy of these agents. According to FierceBiotch, the FDA expressed concern over the use of the therapy, stating, “One must consider whether labeling that specifically indicated a drug for ‘statin-intolerant patients’ could promote condition that is not well understood and encourage some patients to prematurely abandon statins, a class that has robustly established benefits on cardiovascular outcomes.”1 This is a big concern not only for the FDA, but for payers as well.

Although the drugs are anticipated to be approved and to be put to market in the coming months, the FDA still would like to have a detailed review. The FDA is hoping to locate potential safety issues, as well as locking down specific surrogate endpoints in cardiovascular health for these drugs.

As of June 9th, Praluent® has passed the evaluation of the FDA but some questions still remain. The FDA still has not narrowed down the specific patients that will be eligible to receive the product. This will be discussed and narrowed down within the next few days.


  1. John Carroll. FDA asks experts to weigh in on PCSK9 drugs’ market reach for Amgen, Regeneron/Sanofi. Fierce Biotech. June 2015

About Andrew Lyle

Andrew Lyle is an Account Executive at Calcium USA. He holds a B.S. in Pharmaceutical and Healthcare Business from the University of the Sciences. Andrew has worked in various markets such as hematology, neurology, oncology, respiratory, and with many other orphan diseases. Andrew has also held consulting positions specializing in competitive intelligence, strategic planning and also, pricing, reimbursement and market access. When he is not working, Andrew enjoys any physically challenging outdoor activity with his girlfriend and chocolate lab.

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