Merck Secures FDA Approval for Lipfendra, First-in-Class Oral PCSK9 Cholesterol Drug

Merck (NYSE:MRK) announced Thursday it has received U.S. Food and Drug Administration (FDA) approval for Lipfendra, the first oral PCSK9 inhibitor for the treatment of high cholesterol. The new drug offers a convenient alternative to existing injectable therapies for patients with hypercholesterolemia, a condition marked by elevated levels of LDL cholesterol.

Strategic Importance for Merck

The approval provides Merck with a crucial new revenue source as it prepares for the patent expiration of its blockbuster cancer drug, Keytruda, starting in 2028. The loss of patent protection will expose Keytruda to competition from lower-cost biosimilar versions, making the successful launch of new products like Lipfendra essential for the company's long-term financial health.

Market Landscape and Pricing

Lipfendra, also known as enlicitide, enters a market of advanced cholesterol treatments dominated by injectable PCSK9 inhibitors. The drug works by blocking the PCSK9 protein, which regulates cholesterol levels in the blood, a different mechanism from widely used statins that inhibit an enzyme in the liver.

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Merck told Reuters that the list price for Lipfendra will be $10.50 per day, based on a 30-day supply. The drug's oral administration and pricing will be key factors in its competition against established injectable options.

Market Reaction

Investors responded positively to the regulatory milestone. Following the announcement, shares of Merck rose 1.1% in premarket trading on Thursday.