Merck gets US FDA nod for first-in-its-class oral cholesterol drug

RBC Capital Markets analyst Trung Huynh said the drug carries zero contraindications or hypersensitivity warnings for allergic reactions, unlike currently approved injectable competitors.

"Despite a decade of approved injectable options, an estimated 70% (and more) of eligible high-risk atherosclerotic cardiovascular disease patients remain undertreated; driven by injection aversion, prior authorization burden, and limited specialist access in primary care," Huynh said.

Huynh projects Lipfendra to reach peak sales of about $5 billion by 2034.

The FDA's decision was based on two late-stage trials that showed the once-daily pill lowered LDL cholesterol by nearly 60% in patients with hypercholesterolemia.

An ongoing clinical trial is studying the effect of Lipfendra on cardiovascular morbidity and mortality, said Merck.