Alnylam’s Givlaari (givosiran) Receives EC’s Approval for Acute Hepatic Porphyria in Adults and Adolescents

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) with a documented diagnosis of AHP
• The P-III ENVISION study results: 74% reduction in the annualized composite rate of porphyria attacks in AIP patients; attack-free patients during 6mos. treatment (50% vs 16.3%); improvement in pain; reduction in the use of hemin, ALA & PBG
• Givlaari is an RNAi therapy targeting ALAS1 and has received EMA’s ODD and PRIME designation. The EC approval follows the US FDA approval of the therapy received in Nov’2019 and is under priority review in Brazil

Click here ­to­ read full press release/ article | Ref: Businesswire  | Image: Alnylam