A second year internal medicine resident saw on Twitter that a new medication named Aduhelm (aducanuwab-avwa) was approved by the FDA for treating Alzheimer's disease (AD). She has some questions regarding the medication and wanted to obtain more information considering she will likely be receiving questions from patients with AD or caregivers taking care of AD patients. Which of the following are true regarding Aduhelm? Select all that apply.
A. Aduhelm may be given once weekly orally or once monthly intravenously.
B. Aduhelm was approved by the FDA under accelerated approval based on reduction in amyloid beta plaques while on therapy.
C. Patients receiving intravenous therapy should have a brain MRI within one month prior to starting therapy as well as just prior to the 7th and 12th infusions.
D. Angioedema and hypersensitivity reactions have occurred and should be monitored for with each administration, stopping therapy if they occur.
E. Intravenous infusions should be given over an hour via 0.2 or 0.22 in-line micron filter after diluting in 100ml normal saline prior to administration.
Answer with rationale:
The correct answers are B, D, and E. In one of the most controversial FDA approvals in recent memory, Aduhelm was approved by the FDA approximately one month ago and was the first medication approved for treating AD that affects underlying disease progression. The controversy was due in most part as the FDA advisory committee voted nearly unanimously not to approve Aduhelm (10 out of 11 voted against approval with one "uncertain") based on concerns related to overall efficacy. Irregardless, AD is a tremendously difficult disease to manage and likely some pharmacists may be dispensing this in the near future.
Answers B, D, and E are all correct as this is an amyloid-beta directed antibody. Answer A is incorrect as Aduhelm is only available intravenously. Answer C is incorrect as the baseline MRI may be done within one year of the first infusion, not one month. The other MRIs prior to 7th and 12th infusions are correct.
Good luck to those continuing to study!