14 Apr, 2020 New Clinical Results for Givosiran at EASL
An abstract describing new 12-month interim data from the ongoing ENVISION open-label extension (OLE) study of givosiran in patients with acute hepatic porphyria (AHP) has been published online by the European Association for the Society of the Liver (EASL) on the International Liver Congress™ (ILC 2020) website. The data will be presented during the ILC 2020 (London, UK) which was rescheduled to August 25-28, 2020 due to the COVID-19 pandemic.
Long-term dosing with givosiran in the ENVISION OLE study showed sustained reduction in composite annualized attack rate (AAR) with a median AAR of 1.1 through 12 months. Sustained lowering of ALA and PBG levels was observed and was accompanied by durable reductions in hemin use, lower levels of daily pain and ongoing improvements in self-reported quality of life. The safety profile of givosiran was consistent with that observed in the double-blind period, and there were no new safety findings.