Second Amyloid-Targeting Alzheimer's Drug Approved in Europe, Cost Barriers Remain

[Brussels, November 15, 2023] The European Medicines Agency (EMA) today approved Donanemab, a new Alzheimer's disease drug developed by the US pharmaceutical company Eli Lilly, for marketing. This is following the approval of Leqembi by the US FDA in July this year. The world's second targeted therapy for the core pathology of diseases (beta-amyloid protein). However, its high pricing (with an average annual treatment cost of approximately 30,000 US dollars, equivalent to 220,000 yuan) has raised concerns among patient organizations about accessibility.

Key clinical data
Donanemab demonstrated in Phase III trials:

For early-stage patients (at the stage of mild cognitive impairment), it can delay the progression of the disease by up to 35%.

Approximately 40% of the subjects had their amyloid plaques completely cleared in the brain one year after medication.

The main side effects were cerebral edema (ARIA-E, incidence 24%) and microblemings (19%), and regular MRI monitoring was required.

Market and medical insurance challenges
Pricing controversy: Eli Lilly's pricing is similar to that of Leqembi (developed by Eisai and Biogen of Japan), but far exceeds the affordability of ordinary families. The European Patient Association has called for inclusion in medical insurance, but countries such as Germany have expressed hesitation on the basis of "limited efficacy and high cost".

Diagnostic threshold: This drug needs to confirm amyloid protein deposition through PET scan or cerebrospinal fluid test, but most regions around the world lack relevant testing infrastructure.

Industry influence
The development of Alzheimer's disease drugs was once called the "graveyard of the pharmaceutical industry" due to repeated failures. The approval of Donanemab further validates the "amyloid hypothesis". Analysts predict that by 2030, the global market size may exceed 10 billion US dollars, but prices may prevent low - and middle-income countries from benefiting.

[Expert Opinion]
Sarah Walters, a neuroscientist at the University of Cambridge, said: "This is a scientific victory, but the real problem has just begun - how to make patients really have access to the medicine?" According to WHO data, among the over 55 million dementia patients worldwide, 70% live in low-income countries.

【 Follow-up Progress 】
Eli Lilly said it is negotiating with healthcare systems in many countries and plans to conduct affordability pilots in places such as India and Brazil. The National Medical Products Administration of China has accepted the marketing application of Donanemab and is expected to complete the approval in 2024.