World Alzheimer’s Month: New Drugs Can Slow Progression

(1)

Lacanemba, brand name "Leqembi"

• Lead developer is the Japanese pharmaceutical company, Eiasi, working in collaboration with US biotech company, Biogen.

• In November 2022, Eiasi announced its large clinical trial showed the drug slowed clinical declines in people with early-stage Alzheimer’s disease by 27% over the course of 18 months of treatment^[2].

• Received full approval of the Food and Drug Administration (FDA) in the United States in July 2023 for people with mild cognitive impairment or early-stage Alzheimer's disease.
  
  

Leqembi in Australia

• In Australia, an application for assessment by Australia’s Therapeutic Goods Administration (TGA) was lodged by Eiasi in June 2023. If the application process runs smoothly, TGA approval may come through around March 2024. Approval makes the drug available for purchase in Australia.

• The drug costs US$26,500 (around A$40,000) a year. It is unclear how many years a person needs to take it. The clinical trials involved an 18-month period.

• To be subsided under the Australia’s Pharmaceutical Benefits Scheme (PBS), once TGA approval has been received, Eiasi must apply to the Pharmaceutical Benefits Advisory Committee for listing under the PBS. The application assessment takes 17 weeks.

• If the TGA and PBS application processes run smoothly, the drug may be available for purchase in Australia, and subsidised under the PBS, in August 2024. This is the best-case scenario.
  
  

(2)

Donanemab

• Developed by the American pharmaceutical company, Eli Lilly & Co.

• Eli Lilly & Co announced in July 2023, that its Phase III trials showed the drug slowed clinical declines in people with early-stage Alzheimer’s disease by about 35% in 72 weeks^[3].

• In July 2023, Eli Lilly filed an application for full FDA (US) approval of the drug and expects a decision by the end of 2023.

Donanemab in Australia

• Australia’s TGA has not yet announced the receipt of an application for assessment of the drug. No doubt the TGA application will be made by Eli Lilly once FDA full approval has been received.

• The price of the drug has not been announced.

   

(3)

Aducanumab, brand name "Aduhelm"

• Developed by Biogen, in collaboration with Eiasi.

• The clinical trial (EMERGE) showed aducanumab treatment resulted in a 22% slowing of decline on the Clinical Dementia Rating after 14 doses (~10 months)^[4].

• Received accelerated approval from the Food and Drug Administration (FDA) in the United States in June 2021 for the treatment of people with mild cognitive impairment or early-stage Alzheimer's disease. There was some controversary on the FDA’s accelerated approval of the drug.

Aduhelm in Australia

• Biogen Australia withdrew its application for assessment to TGA in May 2022, before a TGA decision made been made. A subsequent TGA Public Assessment Report concluded that the evidence submitted by Biogen Australia “did not satisfactorily establish the efficacy and safety of the product”^[5].

Dementia Activity Poster

Activities for Living in the Moment & Enjoying the Present

Visits to a loved one living with dementia can be an amazing and rewarding experience for both of you. But we know it's not always easy knowing what activities to enjoy with them that will be rewarding, fun and comfortable.

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