
FDA approves first oral PCSK9 inhibitor to lower LDL cholesterol
The US FDA approved Lipfendra, the world’s first oral PCSK9 inhibitor, for adults with high cholesterol including heterozygous familial hypercholesterolaemia, offering an injectable-free option. In trials, it reduced LDL cholesterol by about 56–59% over 24 weeks in patients on maximally tolerated statins, with effectiveness comparable to injectable PCSK9 inhibitors. It is unlikely to be a first-line therapy, and it won’t be available in India immediately, as CDSCO clearance (and possibly local trials) would be required. Doctors say it could help patients who prefer oral treatment or struggle with injections.












