On Thursday, Merck announced that the U.S. FDA has granted approval for its cholesterol medication, marking the first instance of such a drug receiving endorsement from the health authority, reinforcing the company’s strategy to expand beyond its leading cancer treatment, Keytruda.
Starting in 2028, Keytruda will begin to lose significant patent protections, which will expose Merck to competition from potentially cheaper biosimilar alternatives.
Lipfendra is designed for individuals with hypercholesterolemia, characterized by high LDL levels, commonly known as “bad” cholesterol, which can contribute to arterial plaque formation.
Following the FDA’s endorsement, Lipfendra, also known as enlicitide, will be the first oral PCSK9 inhibitor available, providing a new option in a market traditionally dominated by injectable cholesterol medications.
This medication functions by inhibiting the PCSK9 protein, which is crucial for cholesterol regulation, whereas older oral statins target an enzyme responsible for cholesterol production in the liver.
According to the American Heart Association, approximately one in four adults in the United States has elevated LDL cholesterol levels.
The FDA’s approval was based on two pivotal trials, which demonstrated that the once-daily tablet significantly reduced LDL cholesterol levels across a diverse group of patients, including those with familial hypercholesterolemia and those already using statins.
Currently, the market for cholesterol-lowering medications is largely populated by injectable PCSK9 inhibitors such as Amgen’s Repatha and Praluent from Regeneron and Sanofi.
Analysts from Scotiabank, including Louise Chen, indicated prior to the approval that Lipfendra could generate peak sales in the tens of billions of dollars.
Merck’s medication has been awarded the FDA commissioner’s National Priority Voucher, a program designed to expedite the review times for drugs deemed essential for public health or national security.
