Current Players Could Face Competition in the PCSK9 Space

New cholesterol drug from the Medicines Company (MDCO) appears to be more effective.


The Medicines Company recently reported top-line pivotal data on its siRNA candidate inclisiran targeting the PCSK9 (proprotein convertase subtilisin/kexin type 9) pathway for lowering cholesterol. The PCSK9 enzyme destroys receptors in the liver that bind and remove excess cholesterol. PCSK9 inhibitors bind to the enzyme and prevent it from acting, allowing the receptors to function properly.

There are currently two antibody-based PCSK9 inhibitors on the market: Praluent (alirocumab) from Regeneron and Sanofi and Repatha (evolocumab) from Amgen. Based on the positive results for MDCO’s developmental drug, analysts are predicting that Praluent and Repatha will soon face fierce competition, with the potential for Regeneron and Sanofi to pull its product. Amgen has been more successful with its drug to date and may have a sufficiently strong position to retain some market share.


MDCO reported that inclisiran reduces levels of LDL cholesterol with just two injections annually –– compared with 12–26 for the two drugs on the market –– and with a good safety profile. The greater convenience is likely to drive patients to switch to the new drug. Of course, pricing will be an issue as well. With only two injections needed, analysts anticipate that MDCO will have room to maneuver in this respect as well.

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