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rear decades of stagnationthese days, the wheels of Alzheimer’s disease innovation are turning rapidly, from early science to clinical results and commercial implementation.
The next milestone for the industry may be FDA approval of Eli Lilly’s amyloid plaque-busting drug candidate donanemab. The agency announced this week that its advisory committee: Plan to meet on June 10thwhere experts vote on whether to recommend the drug for approval.
Adcomm’s exact agenda has not yet been made public, but independent experts are likely to focus on policy details. Phase 3 study The results showed that donanemab slowed disease progression at 76 weeks.
If approved, donanemab would be the third Alzheimer’s disease drug to hit the market, following two drugs from partners Biogen and Eisai (Aduhelm and Requemby). Aduhelm failed to pass an advisory committee vote but was approved, but was withdrawn from the market and Rekenbi became donanemab’s main competitor.
Sales of Rekenbi were low when the drug was first launched late last year, but the number of patients has steadily increased and sales reached $19 million in the first quarter of this year, Biogen said. report.
Eisai has big plans for this drug in the coming years.Japanese companies expect Leqembi to be Delivering worldwide revenue 290 billion yen, equivalent to more than $1.8 billion today. The company predicted that by 2032, that amount would rise to 1.3 trillion yen, or more than $8.3 billion.
Analysts predict that if Lilly’s donamab is approved by the FDA, two drugs could be registered. combination sale It will reach approximately $10.2 billion in 2030.
These numbers reflect the growing number of people with Alzheimer’s disease, which includes an estimated 6.9 million Americans and is projected to rise to 12.7 million by 2050.
Increased knowledge about Alzheimer’s disease
The advent of amyloid plaque-clearing drugs like Rekenbi and donanemab is not the end of the road for Alzheimer’s disease research. Scientists continue to unravel new secrets of memory-stealing diseases that could lead to better treatments.
This week, researchers at Spain’s São Pau Memory Unit study It points to a potential genetic cause of Alzheimer’s disease, which was once thought to be only a risk factor.
A study of 500 people found that patients with two copies of the gene APOE4 were at increased risk of developing Alzheimer’s disease. They also developed symptoms of Alzheimer’s disease at an earlier age. Understanding more about the genes behind disease progression may allow for early diagnosis, even before symptoms appear.
Many drug development programs have focused on treatments like Rekenbi and donanemab, which target physical symptoms such as amyloid plaques and tau tangles in the brain, but researchers believe the disease is caused by multiple factors. We are finding further reason to believe that it is the result of a combination of
