Shots:

• The submission is based on P-III HELP study evaluating lanadelumab (300mg- q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. It also based on P-III HELP OLE study and interim results of P-III study that evaluated lanadelumab in Japanese patients. If approved- lanadelumab will be available as a pre-filled syringe
• The P-III HELP study results: reduction in mean monthly HAE attacks (87% & 73%)- attack free patients (44% vs 2%). Post-hoc analysis showed attack-free patients at during a steady-state (77% vs 3%)
• Lanadelumab is a mAb targeting plasma kallikrein activity and is an approved therapy in 20+ countries with additional ongoing regulatory submission across the globe

 ­ Ref: Takeda | Image: Takeda