FDA Approves Merck's Once-Daily Lipfendra Pill for LDL Reduction, Eyeing Billions in Sales
Updated
Updated · Bloomberg · Jul 16
FDA Approves Merck's Once-Daily Lipfendra Pill for LDL Reduction, Eyeing Billions in Sales
3 articles · Updated · Bloomberg · Jul 16
Summary
Merck said the FDA cleared Lipfendra on Thursday as a once-daily pill to lower LDL cholesterol, giving the drugmaker a new entry in a market now dominated by injectable therapies.
Lipfendra won approval after showing dramatic reductions in artery-clogging plaque in patients already taking statins, supporting its use as an add-on cholesterol treatment.
The oral format could let Lipfendra replace similar injectable medicines for some patients, potentially broadening uptake beyond current treatment patterns.
Wall Street analysts have said the drug could generate billions of dollars in annual sales, making the approval a potentially significant commercial win for Merck.