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Cover Story: Product Development: LDL Does IMPROVE IT

Merck's IMPROVE-IT bolsters case for PCSK9 inhibitors, but sets bar for outcomes

By Emily Cukier-Meisner, Senior Writer

The long-awaited results from the IMPROVE-IT cardiovascular outcomes trial have been hailed as opening the gates for next-generation cholesterol drugs to gain approval on the basis of LDL reductions alone. That may be true. But the results also set a bar for CV outcomes that newcomers will have to beat to keep payers from limiting access to patients who don't do well on inexpensive current therapies.

The most advanced players, which have PCSK9 inhibitors in registration, already have outcomes studies under way, but there is likely to be an 18-month gap between approval and availability of the study results.

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