Lilly’s Donanemab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Alzheimer’s Disease

Shots:

• The BTD is based on the P-II TRAILBLAZER-ALZ trial assessing donanemab vs PBO in 272 patients with early symptomatic AD who were selected based on cognitive assessments in conjunction with amyloid plaque imaging & tau staging by PET imaging
• The 1EP & 2EP of study @76wks. is the change from baseline in iADRS, ADAS-Cog13 & ADCS-iADL for function & ADAS-Cog13, ADCS-iADL, MMSE & CDR-SB scores while other secondary biomarker EPs includes a change from baseline @76wks. in brain amyloid deposition, brain tau deposition & volumetric MRI
• The company plans to submit BLA for donanemab in late 2021. The therapy is also being evaluated in the ongoing P-III TRAILBLAZER-ALZ 2 study

Click here to­ read full press release/ article | Ref: Lilly | Image: Forbes