IMPROVE-IT’s Mixed Blessing: How Low Does LDL Really Need To Go?
Sponsors of injectable PCSK9 biologics address questions about the implications of the IMPROVE-IT study, in which the soon-to-be-generic oral Zetia helped bring down LDL cholesterol to a very low level.
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Whether FDA agrees that results from ezetimibe cardiovascular outcomes study confirm the LDL hypothesis for non-statin drugs is of keen interest to sponsors of PSCK9 inhibitors and other novel lipid-lowering agents.
TA-8995 is potentially best-in-class and could fill a void in Amgen's portfolio for an oral agent, Exec VP R&D Sean Harper says in an interview. Development will focus on LDL-C lowering, not HDL-C increases.
Diabetics seem to have benefited from Zetia, but not rest of high-risk patients in IMPROVE-IT – suggesting next-step cholesterol drugs might wind up being targeted to subgroups.