FDA Approves Autoinjector version of Lerodalcibep-liga

The FDA has approved an autoinjector formulation of lerodalcibep-liga (LEROCHOL), a third-generation PCSK9 inhibitor, providing an alternative to the existing prefilled syringe without changing the drug’s dose, dosing interval, or formulation. The new delivery option may improve convenience and adherence for sustained LDL-C reduction. Clinical development included more than 2,900 patients across ASCVD, high-risk primary prevention, and familial hypercholesterolemia.

The FDA also approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy.

“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, and we’re pleased that FDA has added labeling across the PCSK9 class converging around that body of evidence,” said Evan Stein, M.D., Ph.D., Founder, CEO and Chief Scientific Officer of LIB Therapeutics. “These studies have resulted in worldwide consensus and alignment of guidelines on new lower targets, and greater additional reductions in LDL-C, for the millions of patients who cannot reach guideline-directed LDL-C goals on maximally tolerated statin therapy. The challenge now, with this newest class of very effective LDL-C lowering agents, is how to make them simple and affordable enough for patients, who must maintain them for what is life-long treatment. LEROCHOL was designed with a patient perspective in mind to achieve exactly that: a robust and sustained LDL-C reduction from a single, small monthly injection that patients self-administer, with room temperature storage of up to 90 days and now in a modern autoinjector device.”

The FDA-approved autoinjector is an innovative, single-use device designed for quick, straightforward patient administration. It is pressure-activated with a single motion and delivers a complete dose in seconds. LEROCHOL in a pre-filled syringe remains available, giving patients and prescribers access to additional administration options. LEROCHOL is the first and only PCSK9 inhibitor that patients self-administer as a monthly, single injection, that can be stored at room temperature conditions for up to 90 days making it easily carried with patients on vacation or business travel.

“Innovation in PCSK9 inhibition cannot stop at the molecule, because how a medicine for life-long therapy fits into a patient’s life is what determines whether they stick with it over the long haul,” said Kristen Miller, Vice President, Brand Communications, LIB Therapeutics. “The monthly dosing by autoinjector is completed in seconds, does not interfere with any oral medications, require overnight fasting, or limit the timing of food and beverage consumption. These features, along with the extended room temperature storage, mean LEROCHOL fits into patients’ lives and not the other way around.”

“PCSK9 inhibitors have been one of the most important advances in cardiovascular medicine of the last 20 years. However, a patient only gets benefit from the lower and sustained LDL-C levels these medications provide if they stay on treatment,” said Dean J. Kereiakes, M.D., FACC, MSCAI, Chairman of The Christ Hospital Heart and Vascular Institute and Professor of Medicine at the University of Cincinnati. “As much as patients expect highly efficacious and safe therapies, they need therapies that fit into their busy lifestyles, and LEROCHOL provides a compelling option on both counts. LEROCHOL provides substantial LDL-C reduction that achieves the 2026 lipid guidelines in the vast majority of my patients with minimal inconvenience. My patients really appreciate having only once-monthly dosing with LEROCHOL, and now the availability of the autoinjector further simplifies this important treatment option.”