In this newsletter, we include information regarding the FDA’s approval of aducanumab to treat Alzheimer’s disease. We also share clinical tips on treating perimenopausal depression, key points from a presentation on psychotropic drug adherence, and our practical research summaries (Quick Takes).
Aducanumab (Aduhelm) for Alzheimer’s Disease
- What was aducanumab approved for?
- On June 7, 2021, FDA approved aducanumab to treat Alzheimer’s disease using the Accelerated Approval pathway, which has caused controversy.
- How does aducanumab work?
- It is a monoclonal antibody that selectively targets aggregated forms of beta-amyloid.
- Through this interaction, aducanumab could reduce the number of amyloid plaques present in the brain, potentially slowing neurodegeneration and disease progression.
- What does Accelerated Approval mean?
- The Accelerated Approval Program allows earlier approvals of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. In the case of aducanumab, the surrogate endpoint is the reduction of amyloid-beta plaque.
- Why is there controversy surrounding the approval of aducanumab?
- The data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit.
- One study (EMERGE) met the primary endpoint, showing a reduction in clinical decline. The second trial (ENGAGE) did not meet the primary endpoint. You can learn more here.
- Does this mean that aducanumab needs no further study given that it is already FDA approved?
- No. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit.
- If a confirmatory trial does not show that the drug provides clinical benefit, FDA can remove the drug from the market.
- Are there any other concerns?
- The American Geriatrics Society states that the potential benefits could outweigh the potential harms.
- In the EMERGE study, there was a substantial incidence of adverse events that led to discontinuation of the drug.
- Individuals developed amyloid-related imaging abnormalities, including edema and microhemorrhages.
FDA’s decision was published in June 2021. Learn more.
Blue Moods and Hot Flashes: Treating Perimenopausal Depression With Vivien K. Burt, M.D., Ph.D.
In this interview, Dr. Vivien Burt discusses depression in women during the perimenopausal stage. Dr. Burt also emphasizes strategies for managing perimenopausal depression, including various hormone therapies.
Interview highlights include the following:
- Antidepressants remain a clear therapeutic option in the treatment of perimenopausal depression.
- Hormone therapy, which may play a key role in addressing symptoms during the perimenopausal stage, should be used at the lowest dose and for the shortest duration possible.
Learn more and earn 0.5 CME credits here.
Psychotropic Drug Adherence
In this presentation, Dr. Martha Sajatovic discusses psychotropic drug adherence. She also guides clinicians in addressing reasons for suboptimal adherence and explains the different approaches for improving it, including managing side effects and partnering with patients.
Technology-Facilitated Adherence Enhancement and Family Involvement
- Clinicians can take advantage of technology to help with adherence supports.
- Low-tech technology, like text messaging, is fast, simple, and works well for many individuals.
- Simply monitoring adherence behavior is unlikely to have a long-term effect.
- Apps can be useful for motivated individuals who feel comfortable using web-based tools.
- Clinicians should try to understand the family members’ attitudes.
- Do not assume that the family will universally or uniformly support adherence promotion.
Learn more and earn 1.0 CME credit here.
Quick Takes: Informing Your Practice
Drug-Induced Hyperthermic Syndromes in Psychiatry
- When a patient presents with markedly elevated temperature and altered mental status, is it neuroleptic malignant syndrome or serotonin syndrome? If you do not have a medication list, some clinical signs may help. Learn more.
Postmarketing Safety Concerns With Esketamine
- Esketamine appears more likely than venlafaxine to cause suicidal ideation. Induction of euphoric mood suggests abuse potential. Caution is warranted. Learn more.
Listen to or read the full volume, and earn 0.5 CME credits here.
References
U.S. Food and Drug Administration. (2021, June 7). FDA’s decision to approve new treatment for Alzheimer’s disease. https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease
Knopman, D. S., Jones, D. T., & Greicius, M. D. (2020). Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by biogen, December 2019. Alzheimer’s & Dementia, 17(4), 696-701.
Hollmann, P., & Lundebjerg, N. E. (2021, June 2). RE: Food and Drug Administration’s Review of Biogen’s drug Aducanumab for Alzheimer’s disease. New York, New York; The American Geriatrics Society.
