LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients
Shots:
- The US FDA has accepted BLA for lerodalcibep (PCSK9 inhibitor) to lower LDL-C in high-risk or ASCVD pts, HeFH/HoFH pts (≥10 yrs), & primary hyperlipidemia (incl. heterozygous) pts, with no advisory committee meeting planned yet (PDUFA: Dec 12, 2025); EMA’s MAA filing expected in Q2’25
- Application was backed by the development program of 2,900 pts incl. LIBerate program, consisting of 5 global P-III trials for CVD or high-risk CVD pts (n>2,300) on maximally tolerated statins & other oral therapies
- LIBerate P-III trials evaluated safety & efficacy of lerodalcibep (SC, QM) vs PBO for 52wks., with ~2,400 pts continuing in a 72wk. OLE trial
Ref: Businesswire | Image: LIB Therapeutics
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