Merck has recently unveiled its promising new oral medication, enlicitide, which may challenge established injection therapies from Regeneron and Amgen in the cholesterol management arena. This development, shared at the American Heart Association’s annual meeting, highlights a significant achievement: enlicitide demonstrated the ability to reduce stubbornly high LDL cholesterol levels by nearly 60%. This could be a game-changer in a cholesterol treatment market projected to reach approximately $47 billion by 2033.
Enlicitide functions by inhibiting the PCSK9 protein, which plays a critical role in regulating LDL cholesterol levels. Elevated PCSK9 levels are linked to increased LDL cholesterol, thereby raising the likelihood of serious cardiovascular events, including heart attacks and strokes. Despite current treatments, including statins, research indicates that fewer than one-third of patients achieve their LDL cholesterol targets. This gap suggests a pressing need for more effective and accessible therapies.
In a clinical trial involving 2,912 participants who either failed to meet LDL goals with standard treatments or who could not tolerate statins, enlicitide recipients experienced a remarkable 55.8% reduction in LDL cholesterol compared to a placebo group after 24 weeks. Removing one outlier with an unusually high LDL value pushed this figure to a striking 59.7%.
Beyond LDL cholesterol, enlicitide also contributed to lower total cholesterol levels and improvements in other cardiovascular risk markers, all while exhibiting a safety profile comparable to that of the placebo group. With plans to submit an application for FDA approval in early 2026, Merck is poised to position enlicitide as a viable alternative to injectable PCSK9 inhibitors like Repatha and Praluent, which have historically faced challenges regarding physician and insurer adoption.
Interestingly, sales figures for these injectable treatments suggest increasing acceptance in the market, with Repatha seeing a 40% year-over-year increase, reaching $794 million, and Praluent experiencing a nearly 13% rise to $215.7 million. Nevertheless, Merck’s oral therapy could simplify the treatment process for many patients. Enlicitide must be taken while fasting, but Koglin reported that 97% of participants managed to adhere to this guideline.
The clinical significance of these findings cannot be overstated. Enlicitide appears to offer a powerful LDL reduction option while remaining user-friendly and safe for a diverse patient population. If approved, it has the potential to significantly impact public health, making strides in the fight against cardiovascular disease and contributing to better health outcomes for many.
