Shots: The EC has granted MAA which is based on P-III ENVISION study assessing Givlaari (2.5 mg/kg monthly, SC) vs PBO in 94 patients aged ≥12yrs. in a ratio (1:1) […]readmore
Tags : Givosiran
Shots: The CHMP’s positive opinion is based on P-III ENVISION study involves assessing Givlaari (SC, 2.5 mg/kg monthly) in 94 patients aged ≥12yrs. with AHP in a ratio (1:1) across […]readmore
Shots: The US FDA approval is based on P-III ENVISION study assessing Givlaari vs PBO in 94 patients with AHP at 36sites across 18 countries. Givlaari got FDA’s approval in […]readmore
Shots: The P-III ENVISION study involves assessing of Givosiran vs PBO in patients with acute hepatic porphyria (AHP) ENVISION study results:74% mean reduction of annualized rate of porphyria attacks; 90% […]readmore
Shots: The P-III ENVISION study involves assessing of Givosiran vs PBO in 94 patients with AHP including patients with acute intermittent porphyria (AIP) across 18 countries in ratio 1:1 The […]readmore