CINCINNATI — LIB Therapeutics has launched LEROCHOL in the United States, introducing a once-monthly injectable PCSK9 inhibitor for adults with hypercholesterolemia.
The privately held biopharmaceutical company said LEROCHOL, also known as lerodalcibep-liga, is approved by the U.S. Food and Drug Administration as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.
The product is available as a 300 mg/1.2 mL injection in a prefilled syringe. LIB said it expects FDA approval of an auto-injector pen version later this year.
The launch includes a direct-to-patient cash-pay option priced at $199 per month, which LIB said represents a substantial discount to other PCSK9 inhibitor cash prices.
LEROCHOL is designed as a once-monthly, single-injection, self-administered treatment. The company said it differs from other PCSK9 inhibitors because it is a small-binding protein rather than a monoclonal antibody. It also has room-temperature stability for up to three months.
“Cardiovascular disease remains the leading cause of death in the United States, and elevated LDL-C is among its most modifiable drivers. Patients who need lower LDL-C levels deserve a clear and affordable path to effective therapies that are also convenient to support long-term adherence. With LEROCHOL, we’re delivering a once-monthly therapy with robust, sustained LDL-C reductions of up to 60% at the best PCSK9 inhibitor cash price,” said Michael Adelman, Chief Commercial Officer of LIB Therapeutics. “We’ve priced LEROCHOL the way we believe medicine should be priced: transparently and predictably, with a focus on value to patients. It’s a meaningful step for patients today, and it sets the stage for our broader commercial launch ahead.”
LIB said its pricing strategy is intended to lower out-of-pocket costs, simplify access and reduce pricing distortions that can affect what patients pay at pharmacies. The company said it is seeking partnerships with self-insured employers, transparent pharmacy benefit managers and other healthcare partners focused on predictable drug pricing.
LEROCHOL requires a prescription from a licensed healthcare provider. LIB said the prefilled syringe launch will support the broader commercial rollout of the drug, with additional details on timing, access and commercial scope expected as plans are finalized.
The most common adverse reactions reported in clinical trials included nasopharyngitis, injection-site reactions and peripheral edema. LIB said LEROCHOL is a recombinant fusion protein and, as with all therapeutic proteins, has the potential for immunogenicity.
