Lerochol gains FDA approval for autoinjector, offering easier once-monthly PCSK9 option

Clinical takeaway: The approval gives clinicians and patients a more convenient administration option for once-monthly Lerochol (lerodalcibep-liga), which may help support long-term adherence to intensive LDL-C lowering therapy. The updated labeling also aligns with longstanding evidence that lowering LDL-C with statins and PCSK9 inhibitors reduces the risk of major adverse cardiovascular events in at-risk adults.

FDA has approved an autoinjector version of Lerochol (lerodalcibep-liga) 300 mg/1.2 mL, a once-monthly PCSK9 inhibitor indicated as an adjunct to diet and exercise for LDL-C reduction in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. The pressure-activated, single-use autoinjector delivers a full dose in seconds and preserves the product’s room-temperature stability for up to 90 days. The prefilled syringe formulation will remain available.

FDA also approved revised label language recognizing that cardiovascular outcomes trials have demonstrated that LDL-C lowering with statins, or with monoclonal antibody PCSK9 inhibitors added to statin therapy, reduces the risk of major adverse cardiovascular events.

The approval is supported by the phase 3 LIBerate clinical development program, which enrolled more than 2,900 patients across populations with established or high-risk cardiovascular disease and heterozygous familial hypercholesterolemia. In these studies, lerodalcibep-liga produced durable LDL-C reductions of 60% or greater in patients with or at high risk for cardiovascular disease and reductions of 59% or greater in patients with heterozygous familial hypercholesterolemia and severely elevated LDL-C levels. Benefits were maintained during long-term follow-up, including a 72-week open-label extension involving more than 2,400 participants.

In the LIBerate-004 trial in heterozygous familial hypercholesterolemia, treatment achieved a placebo-adjusted LDL-C reduction of 58.6% at 24 weeks, with an average reduction of 65% over weeks 22 through 24. The safety profile was generally consistent with the PCSK9 inhibitor class, with injection-site reactions and nasopharyngitis among the most commonly reported adverse events.

“Numerous clinical trials over nearly 40 years have repeatedly established that lowering LDL cholesterol with statins and, more recently, with PCSK9 inhibitors when added to statins, further lowers the risk of major cardiovascular events,” said Evan Stein, MD, PhD, founder, CEO, and chief scientific officer of LIB Therapeutics.

Source: LIB Therapeutics. (2026 Aug 17). U.S. Food and Drug Administration approves an autoinjector version of LEROCHOL® (lerodalcibep-liga) and updated indication