# Repatha

Type: Product

Source: Biotech Intelligence Brief — https://getbiobrief.com/entity/repatha
Canonical HTML page: https://getbiobrief.com/entity/repatha

## Timeline

- **2026-07-16**: FDA Approves Lipfendra — The FDA approved Lipfendra (enlicitide), the first once-daily oral PCSK9 inhibitor, for adults with hypercholesterolemia including inherited forms, based on Phase 3 CORALreef trials showing 56-59% LDL-C reduction.

## Recent coverage (1 stories)

### Merck’s oral PCSK9 inhibitor hits 59% LDL cut, leapfrogging injectable rivals
2026-07-16 22:00:10 · Sentiment: Very Bullish · Impact: 9/10 · Sources: 132

Merck won FDA approval for Lipfendra, a small-molecule oral PCSK9 inhibitor that achieved 56-59% LDL-C reductions in Phase 3. This breakthrough in oral delivery challenges the dominance of injectable biologics from Amgen and Sanofi/Regeneron.
Full story: https://getbiobrief.com/story/merck-lipfendra-fda-approval-oral-pcsk9-59-percent

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