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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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