Logo

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

Share this

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

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

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions