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MSD Wins FDA Approval for Cholesterol Pill to Help Plug Keytruda Void

MSD (Merck) has received FDA approval for the first PCSK9 inhibitor in pill form for patients with high cholesterol. This milestone puts the company ahead of competitors and helps fill the revenue gap expected after Keytruda's patent expiration.

July 17, 2026
2 min read
Source: Pharmaceutical Technology
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MSD, known as Merck (MRK) in the US, has received FDA approval for the first PCSK9 inhibitor in pill form for patients with high cholesterol. This achievement positions the company ahead of rivals and helps bridge the void left by Keytruda after its patent expiration.

The Product

The new drug is the first oral PCSK9 inhibitor (pill), offering a significant competitive advantage over current injectable treatments. It works by inhibiting the PCSK9 protein, increasing the liver's ability to remove LDL (bad) cholesterol from the blood.

Pricing and Availability

The company has not yet announced the drug's price or market availability. Merck is expected to set pricing based on its efficacy compared to existing therapies.

Competition

MSD's drug outpaces competitors such as Repatha (Amgen) and Praluent (Sanofi), which are administered via injection. Other companies are developing similar pills, but MSD is first to market.

Potential Impact on the Company

This drug represents a major opportunity for Merck to offset the expected decline in Keytruda revenues, one of the world's best-selling drugs, after its patent expiration. The new drug is expected to bolster the company's cardiovascular portfolio.

Frequently Asked Questions

The FDA approved the first PCSK9 inhibitor pill from MSD for high cholesterol.

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This article was rewritten in Wrqti's editorial style based on information from the original source above. Content is informational only — not investment advice.