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The F.D.A. Approves a New Pill to Slash Cholesterol Levels
The New York Times • • business
Key Points:
- The FDA approved a new daily pill called Lipfendra (enlicitide) by Merck, which significantly lowers LDL cholesterol levels beyond what statins can achieve by inhibiting the PCSK9 protein.
- Clinical trials show Lipfendra can reduce LDL cholesterol to 50 or 60 mg/dL or lower, compared to typical levels above 100 mg/dL in untreated adults.
- New cholesterol guidelines recommend LDL levels below 70 mg/dL for those at above-average risk and below 55 mg/dL for high-risk patients; Lipfendra helps meet these targets.
- Lipfendra will be priced at $315 per month, cheaper than existing injectable PCSK9 inhibitors that cost $500 to $600 monthly and are less preferred by patients due to injection administration.
- Cardiologists praised the approval and pricing, expressing hope that the pill’s convenience and lower cost will increase patient access and improve cholesterol management.
