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BioArctic Partner Eisai Reports P-III (Clarity AD) Study Results of Lecanemab for the Treatment of Alzheimer's Disease

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BioArctic Partner Eisai Reports P-III (Clarity AD) Study Results of Lecanemab for the Treatment of Alzheimer's Disease

Shots:

  • The P-III confirmatory (Clarity AD) study evaluates lecanemab (10mg/kg, BIW) in a ratio (1:1) in 1795 patients with early AD
  • The trial met the 1EPs & 2EPs i.e., reduction in clinical decline on the global cognitive & functional scale, 27% in CDR-SB @18mos. in the ITT population, significant changes in CDR-SB from baseline as early as 6mos. The 2EPs showed a significant result, a change from baseline at 18mos. in amyloid levels in the brain measured by amyloid PET, ADAS-cog 14, ADCOMS & the ADCS MCI-ADL
  • The total incidence of ARIA (ARIA-E & ARIA-H) was 21.3% vs 9.3%. Eisai plans to discuss the results with regulatory authorities in the US, Japan & EU with an expected filing for traditional approval in the US & MAA in Japan and the EU at the end of Q1’23

Ref: PR Newswire | Image: BioArctic

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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