Shire’s Takhzyro IV (lanadelumab) Receives EU’s Approval for Hereditary Angioedema
Shire’s Motegrity (prucalopride) Receives FDA Approval for Chronic Idiopathic Constipation (CIC) in Adults
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
Click here to read full press release/ article | Ref: Shire | Image: Shire