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

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