Amgen adds data for Repatha to boost profile
- Amgen's GLAGOV imaging study has met its primary and secondary endpoints in a Phase 3 study. In the 968-patient study of patients with coronary artery disease on optimized statin therapy, Repatha "modifies the underlying process of atherosclerosis." The study didn't spot any new safety concerns.
- No further details of the data have been released; more results will be presented at the American Heart Association (AHA) Scientific Sessions in November 2016.
- Repatha is approved in over 40 countries, including North America, Japan and the EU, but sales of this high-cost therapeutic have so far been slow.
The PCSK9 inhibitors are an active area of research, but are approved only for specific patient populations, and according to the developers, their high prices are built to take into account patients' poor adherence to statins and the associated increased healthcare costs. These high costs have led to a challenging marketplace. A study in JAMA, refuted by Amgen, claimed that these high-cost drugs were not as cost effective as other options. Payers and physicians are reported to be skeptical, and therefore uptake has been slow, and this has been blamed on both cost and lack of data.
Amgen is on the case, data-wise. Its GLAGOV Phase 3 study is looking at 968 patients to see whether Repatha (evolocumab) can reduce the volume of plaques.
"We are pleased with the positive results of this landmark study showing that Repatha modifies the underlying process of atherosclerosis," said Sean Harper, head of R&D at Amgen.
Amgen is also carrying out an outcomes study, tagged FOURIER, which aims to see whether treatment with Repatha or placebo on top of optimized statin therapy cuts the risk of major cardiovascular events in patients with atherosclerotic disease. Topline results are expected in first quarter 2017. However, what payers are really calling for is real-world data, which shows how patients use the drug outside of the confines of clinical trials. This can be used as a basis for outcomes-based contracts, like those negotiated by Cigna with Amgen and Sanofi/Regeneron for their respective PCSK9 inhibitors.
Another way to make drugs more "marketable" is through formulation and delivery. Repatha was originally approved as a single injected dose every two weeks, or three sequential shorts once a month. In July 2016, the FDA approved the on-body Pushtronex hands-free infuser, which can deliver Repatha as a once-monthly subcutaneous injection over up to 9 minutes. This could improve convenience and could therefore improve compliance, always a bonus for payers.
A report from MarketResearchReports suggests that PCSK9 inhibitors still have potential to drive the dyslipidemia market. This was worth $15.4 billion in 2013, and is predicted to climb to $37.9 billion by 2023. An estimated 71% of this will be from branded drug sales. Yet, where the class fits in compared with older, lower-cost competitors is still in the air.
- Amgen Statement
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