Regeneron/Sanofi’s PSCK9 Inhibitor Might Need Two-Week Dosing Schedule
This article was originally published in The Pink Sheet Daily
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.
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Aegerion says feedback from key opinion leaders and market research indicate the market for its homozygous hypercholesterolemia drug may be as many as 3,000 patients; FDA estimates put the number at 315.
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.
Publication of full Phase II results for Sanofi/Regeneron’s SRA236553 in the New England Journal of Medicine put the focus on the PCSK9 class days ahead of the annual AHA meeting, where Amgen and Pfizer will be presenting new data for rival drugs.