Astrea Bioseparations acknowledges FDA approval of LIB Therapeutics’ LEROCHOL™

Astrea Bioseparations congratulates LIB Therapeutics on the recent U.S. Food and Drug Administration approval of LEROCHOL™ (lerodalcibep-liga) for the treatment of adults with elevated low-density lipoprotein cholesterol (LDL-C). This approval marks a significant advancement in cardiovascular disease management and represents an important addition to the therapeutic options for patients who struggle to meet LDL-C targets with existing treatments.

LEROCHOL™, a novel, third-generation PCSK9 inhibitor developed by LIB Therapeutics, is designed to provide robust and sustained reductions in LDL-C through a convenient, once-monthly subcutaneous administration. The approval reflects positive outcomes from the comprehensive Phase 3 LIBerate clinical program, which demonstrated meaningful lowering of LDL-C in a broad patient population, including those with heterozygous familial hypercholesterolemia and other high-risk groups.

Astrea Bioseparations is proud to support the biopharmaceutical industry through the supply of critical materials used in the capture step of therapeutic production processes. Being part of the supply chain for products like LEROCHOL™ emphasizes the importance of reliable, high-performance bioseparation technologies in enabling the development and manufacture of innovative medicines.

Frederic Vanderhaegen, CEO of Biotage, said:

This milestone highlights the strength of our long-standing collaboration, spanning development through to production. We congratulate LIB on this important achievement and look forward to continuing to support their mission of bringing meaningful treatments to patients.