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

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

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

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

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Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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