FDA approves Lerochol autoinjector, updated cardiovascular indication

The FDA has approved a self-administered autoinjector for Lerochol (lerodalcibep-liga) and updated the drug’s label to state that lowering low-density lipoprotein (LDL) cholesterol with PCSK9 inhibitors like it, added to statin therapy, reduces the risk of major adverse cardiovascular events (MACE), LIB Therapeutics shared in an announcement today.

Lerochol is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor from LIB Therapeutics that the FDA first approved in December 2025 as a prefilled syringe for adults with high LDL cholesterol. The autoinjector approved this week gives patients an alternative way to take the once-monthly injection. LIB Therapeutics said the pressure-activated device delivers a full dose in seconds with a single motion.

The drug’s active ingredient is an engineered protein called an adnectin, fused to human serum albumin to extend how long it stays in the body. LIB Therapeutics said that design allows Lerochol to be stored at room temperature for up to 90 days. The company said that’s convenient for patients who travel.

Lerochol is indicated as an adjunct to diet and exercise to lower LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), an inherited condition that causes dangerously high cholesterol from an early age. The original approval was based on the phase 3 LIBerate Clinical Trial Program, which enrolled more than 2,900 adults with cardiovascular disease, or at high or very high risk for it, including some with HeFH.

Participants took monthly Lerochol injections for up to 52 weeks, and more than 2,400 continued into a 72-week open-label extension. LDL-C fell by at least 60% in patients with or at high risk for cardiovascular disease and at least 59% in those with HeFH, according to LIB Therapeutics.

In the HeFH-focused LIBerate-004 trial within that program, LDL-C dropped by a placebo-adjusted 58.6% at 24 weeks; averaged across weeks 22 through 24, the reduction reached 65%. The company said no serious treatment-related side effects turned up in the long-term extension studies. The most common reactions in the broader trial population were nasopharyngitis, affecting 15% of patients compared with 14% on placebo, injection-site reactions, affecting 12% compared with 5%, and peripheral edema, or swelling in the legs, affecting 2% compared with less than 1%. Injection-site reactions were the top reason patients discontinued treatment, affecting 1% of the Lerochol group and none on placebo.

Evan Stein, M.D., Ph.D., founder, CEO and chief scientific officer of LIB Therapeutics, said the FDA added similar cardiovascular-benefit language “across the PCSK9 class,” aligning federal labeling with the lower LDL-C targets many cardiologists already follow.

LIB Therapeutics is selling Lerochol, in both the autoinjector and prefilled syringe, for $199 a month through its direct-to-patient cash-pay program, LEROCHOL Direct. The company said insurance coverage is expected to expand gradually over the course of 2027, and the autoinjector itself isn’t expected to reach patients until January 2027.

LIB Therapeutics is marketing Lerochol as the only PCSK9 inhibitor patients self-inject as a single monthly dose as an effort to improve adherence to cholesterol treatment.

“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,” 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, said in the news release. “My patients really appreciate having only once-monthly dosing with Lerochol, and now the availability of the autoinjector further simplifies this important treatment option.”