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Will New Injectables Sell In An Oral, Mainly Generic Cholesterol World?

Executive Summary

PCSK9 inhibitors have come into vogue based on potent LDL-lowering in early studies. But the up-and-coming biologics still face questions about how they will fit in a market dominated largely by proven, oral generics.

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Momentum Builds For PCSK9 Class, But Proof Of Safety Still Thin

Amgen’s Phase II program for its PCSK9 inhibitor AMG 145 impresses when it comes to lowering cholesterol. But the studies were only 12 weeks long and the bigger test for monoclonal antibodies like AMG 145 and Sanofi/Regeneron’s rival REGN727 is proof of longer-term safety in bigger trials.

Amgen Keeping Dosing Options Open For Cholesterol Buster AMG 145

A monthly dose of Amgen’s PCSK9 inhibitor lowers LDL significantly with a good tolerability profile in two Phase II studies. Reporting results for the RUTHERFORD trial in the journal Circulation, investigators compare AMG 145 favorably for heterozygous familial hypercholesterolemia to a range of rivals, including Sanofi’s REGN 727, Genzyme’s mipomersen and Aegerion’s lomitapide.

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