Shire's Takhzyro IV (lanadelumab) Receives EU's Approval for Hereditary Angioedema
Shots:
- The approval is based on P-III HELP study results assessing Takhzyro (300 mg q2w- 300 mg q4w- 150 mg q4w) vs PBO in 125 patients with HAE aged ≥12 yrs.
- P-III HELP study results: no. of monthly attacks (87%- 73%); fewer moderate to severe attacks 83%; attacks that needed on-demand treatment 87% ; reduction in attack 89%; attack free 44% vs 2%- AE-QoL 81% vs 37%
- Takhzyro is a mAb helps in reducing plasma kallikrein activity- approved for prevention of HAE attacks in the US and Canada on 23 Aug-2018 and 19 Sep-2018
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