Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

December 11, 2020 Auto Bot aducanumab, Alzheimer Disease, Biogen, regulatory, reports 0

Shots:

  • The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment
  • The secondary objectives of the study were to assess the effect of monthly doses of aducanumab on the clinical decline as measured by MMSE, ADAS-Cog 13 & ADCS-ADL-MCI. MHLW will review the application through the standard review process
  • Aducanumab is an investigational mAb that is under the US FDA’s PR with an anticipated PDUFA date as Mar 7, 2021 and is also under review with the EMA

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Barron’s

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