The Readout Loud 378: Merck's heart disease win and the FDA's new drug regulator
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Nov 13, 2025 Dean Li, Head of R&D at Merck, discusses the groundbreaking results of Merck's oral PCSK9 candidate, enlicitide, which shows impressive LDL cholesterol reduction comparable to injectables. He explores the challenges of making effective heart disease treatments more accessible and the potential public health impact of wider adoption. The conversation also touches on FDA leadership changes and hopes for regulatory pathways that prioritize patient access while maintaining safety. Li emphasizes the importance of innovating beyond injectables and targeting new areas in cardiometabolic health.
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Oral PCSK9 Pill Matches Antibody Efficacy
- Merck's oral PCSK9 pill, enlicitide, produced LDL-lowering comparable to injectable antibodies in phase III trials.
- The drug showed a placebo-like safety profile and 97% compliance in the study.
Regulatory Path: Approve On Biomarker, Confirm Outcomes
- Merck will file for approval based on LDL-biomarker reduction even before outcomes data are available.
- The company is running an outcomes trial, but expects the biomarker-outcome relationship to predict similar cardiovascular benefit as antibodies.
Make The Pill Fit Daily Routines
- Design the pill to integrate into patients' daily medication routines to improve uptake and adherence.
- Aim for insurance coverage and pricing that treats the pill like other common cardiovascular medicines.