Biogen commentary on Aduhelm and Down syndrome
Biogen's notice on 8/4/21 offered as an educational resource for healthcare providers in response to an unsolicited request by Dr. Seth Keller, co-President of the NTG. The notice indicated that aducanumab-avwa has not been studied in persons with Down Syndrome associated Alzheimer’s disease (DS AD), and there there are no data on the efficacy and safety in this population. The notice cites the work of Cummings et al (2021) which acknowledges as that there are many differences between Down syndrome and late onset AD and as such, it is recommended against treating persons with Down syndrome with aducanumab-avwa until more data are available. According to Cummings et al., persons with Down syndrome may eventually become eligible for treatment after additional studies have been conducted and additional data are accrued for this group of individuals. It also cites various sources, including the NTG, recommending the generation of more applicability and use protocols.