Alnylam’s Givlaari (givosiran) Receives the US FDA’s Approval as the First Therapy for Acute Hepatic Porphyria

 Alnylam’s Givlaari (givosiran) Receives the US FDA’s Approval as the First Therapy for Acute Hepatic Porphyria

Alnylam’s Givlaari (givosiran) Receives the US FDA’s Approval as the First Therapy for Acute Hepatic Porphyria

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 less than four months following its NDA acceptance
  • The P-III ENVISION study resulted in 70% fewer porphyria attacks in patients, reduction in intravenous hemin use, reductions in urinary aminolevulinic acid and urinary porphobilinogen. Additionally, in Aug’2019, Alnylam signed a promotional agreement with Ironwood for GIVLAARI to raise awareness of AHP among gastroenterologists and other HCPs in the US
  • Givlaari is the world’s first approved GalNAc-conjugate RNA therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) and has received FDA’s BT & ODD and EMA’s PRIME & ODD with its anticipated availability in the US by the year-end

Source 1, Source 2 to­ read full press release/ article | Ref: FDA, Business wire  | Image: Pharmaceutical Technology

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

Related post