Shares of Merck MRK rose more than 3% on Thursday after the company announced that the FDA approved enlicitide as the first oral PCSK9 inhibitor to reduce low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) in adults with hypercholesterolemia (high cholesterol). The drug will be marketed under the brand name Lipfendra.
The agency’s approval also covers patients with heterozygous familial hypercholesterolemia (HeFH), an inherited condition in which a person receives a mutated gene associated with high cholesterol from one parent.
The approval is supported by data from two phase III studies, CORALreef Lipids and CORALreef HeFH, which evaluated a 20 mg once-daily dose of the drug over 24 weeks. While data from the CORALreef Lipids study showed that Lipfendra reduced LDL-C by 56% versus placebo in patients with hypercholesterolemia, the CORALreef HeFH study demonstrated a 59% reduction compared to placebo in HeFH patients.
The drug is expected to launch in the coming weeks at a list price of $315 per month, significantly lower than the list prices of currently available PCSK9 injectables, including Amgen’s AMGN Repatha and Novartis’ NVS Leqvio. This competitive pricing was not unexpected, as Merck had previously indicated that it intended to position Lipfendra as an affordable treatment under its agreement with the U.S. government to expand access to medicines and lower costs for citizens. Although the drug’s commercial success will ultimately depend on Merck’s net pricing strategy and payer adoption, its oral formulation could provide a meaningful competitive advantage over injectable PCSK9 therapies.
MRK’s Stock Performance
Year to date, the company’s shares have risen 21% compared with the industry’s 9% growth.
More on Merck’s Lipfendra
The drug is currently being evaluated in a late-stage cardiovascular outcomes study to determine whether it can reduce the risk of major adverse cardiovascular events, as well as cardiovascular morbidity and mortality.
Lipfendra could become an important long-term growth driver for Merck. As the first once-daily oral PCSK9 inhibitor, the drug has the potential to expand the use of this class by offering a convenient alternative to injectable therapies, potentially improving patient uptake and adherence. If successful, Lipfendra could emerge as a meaningful revenue contributor and help diversify Merck’s growth drivers as the company prepares for the loss of exclusivity for its blockbuster cancer therapy, Keytruda, later this decade.
Merck & Co., Inc. Price
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MRK’s Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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