Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan

March 12, 2021 Auto Bot Japan, MHLW, NDA, regulatory, reports, Submission, Takeda, Treatment 0

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

Click here ­to­ read full press release/ article | Ref: Takeda | Image: MedCity News

The post Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan first appeared on PharmaShots.