FDA Approves Repatha – Another New Powerful Cholesterol-Lowering Drug

Twitter Summary: @US_FDA approves Repatha to lower “bad” cholesterol in ppl who can’t take more #statins

The FDA recently announced approval for Amgen’s Repatha (evolocumab), the second in a new class of injectable cholesterol lowering medications called PCSK9 Inhibitors. These medications increase the body’s ability to remove LDL cholesterol (the “bad” kind) from the blood – they are a bit more "supercharged" than statins and may be particularly useful for anyone who can't take statins. In clinical trials, Repatha led to a 61% greater reduction in LDL cholesterol after 12 weeks compared to standard treatment alone; it also resulted in a possible reduced risk of heart disease. Praluent, which was approved on July 24, 2015, was the first-ever PCSK9 inhibitor approved in the US. While statins will likely remain the standard therapy for lowering cholesterol for those that do not have any problem taking them, Repatha and Praluent have the potential to help the many people who report having side effects with statins, including muscle pain and memory loss. Who is that? It’s estimated that 10-20% of people have problems taking statins – that’s why we care about this so deeply!

Specifically, Repatha is approved for two populations who are unable to take higher doses of statins:

• Adult patients with familial hypercholesterolemia, an inherited genetic condition that cause high levels of LDL cholesterol.

• Adult patients with clinical atherosclerotic cardiovascular disease (hardening of the arteries) – a buildup of plaque in the arteries that can lead to conditions such as heart attacks and strokes.

As we understand it, Repatha will be available in a single-use, prefilled auto-injection device (like an EpiPen) to be taken every two weeks or once a month. Repatha will have a wholesale cost of $542 for one 140 mg prefilled autoinjector or syringe, which translates to about $14,000 annually (for the twice-weekly administration). This pricing, while very expensive, is effectively comparable to that of Praluent ($1,120 for a 28-day supply of Praluent vs. $1,084 for a 28-day supply of Repatha), and the out-of-pocket costs should be significantly lower for those fortunate enough to have insurance plans that cover the drug. In order to get more patients to use the drug, Amgen is offering a “RepathaReady” patient support program. The program will include one or more months of free Repatha through the Repatha Patient Start Program (for those waiting on pending insurance coverage), the Repatha $5 co-pay card for eligible commercial patients, insurance coverage support, and injection training.

Ongoing studies are observing Repatha’s long-term effects on heart safety. Depending on the results of these trials, Repatha may later be expanded for use in a wider patient population. Reimbursement will certainly be key for Repatha and Praluent, and we are hopeful that the impressive clinical data may convince insurance companies of the benefits of these therapies. -KC/AJW/ER

[Photo: Amgen, Inc.]