The US Food and Drug Administration on 16 July approved the first oral drug in the class of PCSK9 inhibitors, offering a daily pill as an alternative to injectable treatments for lowering LDL cholesterol. Merck’s enlicitide, to be sold as Lipfendra, reduced LDL-C by 56% in patients with hypercholesterolaemia and by 59% in those with heterozygous familial hypercholesterolaemia after 24 weeks in two phase 3 trials, compared with placebo. The tablet, priced at $315 per month in the US, undercuts the $500–$600 monthly cost of existing injectable PCSK9 inhibitors such as Repatha and Praluent, and is expected to reach pharmacies within weeks.

PCSK9 inhibitors work by blocking a protein that interferes with the liver’s ability to clear LDL from the bloodstream, a mechanism distinct from that of statins. The oral formulation removes the need for periodic injections, a barrier for some patients. Merck has launched a large outcomes study to determine whether the substantial LDL reductions translate into fewer heart attacks, strokes and cardiovascular deaths—a standard post-approval requirement that will shape long-term clinical adoption.

Separately, new guidelines from the American College of Cardiology and the American Heart Association, published in March 2026, recommend that all adults undergo a once-in-a-lifetime measurement of lipoprotein(a), or Lp(a). This cholesterol fraction is determined almost entirely by genetics, remains largely unaffected by diet or statins, and, when elevated above roughly 50 mg/dL (125 nmol/L), is associated with a threefold higher risk of myocardial infarction. An estimated one in five people carry high levels, yet most have never been tested. No approved therapy specifically targets Lp(a), but Novartis’s pelacarsen, a monthly injection, is in the phase 3 Horizon trial with more than 8,000 participants; earlier data showed it can lower Lp(a) by around 80%, though results on cardiovascular outcomes are still awaited.

Viewed from Washington, the twin developments mark a push toward more individualised cardiovascular prevention. The pill expands options for the roughly one in four US adults with elevated LDL, while the screening recommendation aims to uncover a hidden genetic risk that current routine tests miss. For now, patients found to have high Lp(a) are advised to control other modifiable factors more aggressively. The next factual milestones are the cardiovascular outcomes data from Merck’s post-approval trial and the Horizon study, which will determine whether these new tools deliver on the promise of preventing actual clinical events.