Merck gets FDA approval for first oral PCSK9 cholesterol pill

Merck received FDA approval for Lipfendra (enlicitide), the first once-daily oral PCSK9 inhibitor for lowering LDL cholesterol, reducing it by up to 59% in trials and directly competing with injectable alternatives from Amgen, Regeneron, and Sanofi. If you build patient adherence software, data platforms, or digital therapeutics for chronic disease, Merck just handed injectables their exit date. The move from needle to daily pill reshapes the entire care workflow - and every incumbent injectable maker now needs to rebuild distribution, patient support, and pricing strategies for an oral world.