Amgen Keeping Dosing Options Open For Cholesterol Buster AMG 145
This article was originally published in The Pink Sheet Daily
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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The Metabolic and Endocrinologic Advisory Committee accepts LDL lowering as endpoint for homozygous hypercholesterolemia drugs, backing approval of Aegerion’s lomitapide by 13-2 and Genzyme’s mipomersen by 9-6, but hones in on the need for better surrogates for cardiovascular morbidity and mortality.
Fully human antibody for hypercholesterolemia is set to enter Phase III next month, and while the firms aren’t discussing the protocol, recent data suggest that REGN727/SRA236553 may need dosing every two weeks, rather than the more convenient monthly schedule.