Alnylam’s Givlaari (givosiran) Receives CHMP’s Positive Opinion to Treat Acute Hepatic Porphyria in Adults and Adolescents

 Alnylam’s Givlaari (givosiran) Receives CHMP’s Positive Opinion to Treat Acute Hepatic Porphyria in Adults and Adolescents

Alnylam’s Givlaari (givosiran) Receives CHMP’s Positive Opinion to Treat Acute Hepatic Porphyria in Adults and Adolescents

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 18 countries at 36 sites
  • The CHMP’s positive opinion follows the US FDA’s approval of Givlaari received in Nov’2019. If approved in EU, givosiran will be commercialized under the brand name Givlaari
  • Givosiran is an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) and has received EMA’s PRIME and ODD for the same indication

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

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