Shots:
The P-III (FOURIER) OLE studies evaluate the safety & tolerability of Repatha vs PBO in 6,635 patients with ASCVD for a median follow-up of ~5yrs.
The results showed a significant & sustained reduction in LDL-C levels with 80% of patients achieving an LDL-C level of <55mg/dL, LDL-C reduction of 58% from baseline was consistent over long-term follow-up (260wk.) with no new safety results
In an additional prespecified exploratory analysis, the therapy showed a lower rate of major adverse CV events, incl. CV death with 20% relative risk reduction for major CV & 23% RRR for CV death. The company will share the results with the regulatory authority & the therapy is being evaluated in (VESALIUS-CV) trial
Ref: Amgen | Image: Amgen
