29 Aug, 2020 New Results for GIVLAARI® (givosiran) at The Digital International Liver Congress™ 2020
During The Digital International Liver Congress™ 2020, we shared new interim data from the Phase 1/2 open-label extension (OLE) study of GIVLAARI® (givosiran) in acute hepatic porphyria (AHP), as well as encore 12-month interim data from the OLE period of the ENVISION Phase 3 study of GIVLAARI.
New interim results from the Phase 1/2 OLE study of GIVLAARI demonstrated maintenance, and potentially enhancement, of clinical activity with a mean time of 27.9 months and up to 41 months of continuous treatment with GIVLAARI. Long-term treatment with GIVLAARI led to consistent and durable aminolevulinic acid and porphobilinogen reductions of ≥89 percent at Month 30, with an acceptable and consistent safety profile, and with exploratory endpoints showing reductions in the annualized rate of composite porphyria attacks and hemin use of >90 percent.
The findings are consistent with 12-month interim data from the OLE period of the ENVISION Phase 3 study of GIVLAARI, which demonstrated sustained efficacy and safety with long-term dosing, with evidence for potentially improved efficacy over time. Together, the Phase 1/2 and ENVISION Phase 3 OLE data reinforce the long-term therapeutic benefit of GIVLAARI in people with AHP.